FDA Product Code
FDA Product Code MWI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2300
510(k) Clearances — 308 records · page 3 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K082787 | VITAL SIGNS MONITOR, MODEL: MD500B | Beijing Choice Electronic Technololgy Co., Ltd. | 2009-01-12 | Traditional | PDF ↗ |
| K082008 | BIONET BM3PLUS PATIENT MONITOR | Bionet Co., Ltd. | 2008-12-11 | Traditional | PDF ↗ |
| K082812 | OMRON MODEL HBP-2070 VITAL SIGNS MONITOR | Omron Healthcare, Inc. | 2008-10-22 | Special | PDF ↗ |
| K082564 | HYPERQ SYSTEM | Biological Signal Processing, Ltd. | 2008-10-20 | Special | PDF ↗ |
| K082685 | GALAXY 55 | Larsen & Toubro Limited | 2008-09-26 | Traditional | PDF ↗ |
| K082256 | LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE | Integrated Medical Systems, Inc. | 2008-09-26 | Traditional | PDF ↗ |
| K081552 | SKYLINE 55 | Larsen & Toubro Limited | 2008-07-31 | Traditional | PDF ↗ |
| K080141 | PC ECG 1200W SYSTEM | Norav Medical , Ltd. | 2008-04-25 | Special | PDF ↗ |
| K080173 | STAR 55 | Larsen & Toubro Limited | 2008-02-08 | Traditional | PDF ↗ |
| K073094 | VITALLINK3 MOBILE VITAL SIGNS SYSTEM | Telemedic Systems, Ltd. | 2008-01-04 | Special | PDF ↗ |
| K071802 | TESLA GUARD, MODEL EFT G04 | Mammendorfer Institut Fur Physik Und Medizin GmbH | 2007-11-09 | Traditional | PDF ↗ |
| K072516 | MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR | Midmark Diagnostics Group | 2007-10-18 | Traditional | PDF ↗ |
| K071472 | PLANET 55 | Larsen & Toubro Limited | 2007-09-21 | Traditional | PDF ↗ |
| K071982 | MODIFICATION TO: UNITY NETWORK ID | Ge Medical Systems Information Technologies | 2007-09-21 | Special | PDF ↗ |
| K072389 | MODIFICATION TO HYPERQ SYSTEM | Biological Signal Processing, Ltd. | 2007-09-18 | Special | PDF ↗ |
| K071606 | BIOSIGN CENTRAL STATION | Obs Medical | 2007-08-31 | Traditional | PDF ↗ |
| K071645 | MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S | Omron Healthcare, Inc. | 2007-07-02 | Special | PDF ↗ |
| K070624 | HYPERQ SYSTEM | Biological Signal Processing, Ltd. | 2007-04-06 | Special | PDF ↗ |
| K063840 | XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION | Witt Biomedical Corp | 2007-02-06 | Traditional | PDF ↗ |
| K063547 | CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM | Witt Biomedical Corp | 2006-12-21 | Special | PDF ↗ |
| K063055 | VS-800 VITAL SIGNS MONITOR | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006-12-21 | Traditional | PDF ↗ |
| K063087 | MODIFICATION TO MODEL 750 SERIES MONITOR | Cas Medical Systems, Inc. | 2006-12-11 | Special | PDF ↗ |
| K063419 | MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) | Welch Allyn Protocol, Inc. | 2006-12-04 | Special | PDF ↗ |
| K060756 | MEDLOG, MODEL 1-0-10 | Bmc Gesellschaft Fur Medizintechnik Mbh | 2006-10-30 | Traditional | PDF ↗ |
| K061816 | GALAXY | Larsen & Toubro Limited | 2006-07-12 | Traditional | PDF ↗ |
| K061590 | SMDIE DEVICE INTERFACING SYSTEM | Siemens Medical Solutions Health Services Corporat | 2006-06-21 | Traditional | PDF ↗ |
| K053193 | PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006-05-18 | Traditional | PDF ↗ |
| K053234 | PM-9000 EXPRESS PATIENT MONITOR | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006-05-04 | Traditional | PDF ↗ |
| K060712 | VITELCARE C-TURTLE PATIENT MONITORING SYSTEM | Visual Telecommunications Network, Inc. | 2006-04-19 | Special | PDF ↗ |
| K053112 | BIOSIGN | Oxford Biosignals Limited | 2006-01-31 | Traditional | PDF ↗ |
| K060058 | STELLAR 404T | Larsen & Toubro Limited | 2006-01-20 | Traditional | PDF ↗ |
| K053462 | 3160 MRI PATIENT MONITORING SYSTEM | Invivo Corporation | 2006-01-18 | Special | PDF ↗ |
| K052119 | TESLAGUARD, MODEL EFT G04 | Mammendorfer Institute For Physics & Medicine GmbH | 2006-01-03 | Traditional | PDF ↗ |
| K051896 | MODEL 750E SERIES MONITOR | Cas Medical Systems, Inc. | 2005-12-16 | Traditional | PDF ↗ |
| K053027 | VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) | Welch Allyn, Inc. | 2005-11-22 | Special | PDF ↗ |
| K050399 | MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 | Invivo Research, Inc. | 2005-08-26 | Traditional | PDF ↗ |
| K051897 | TRIO MONITOR | Datascope Corp. | 2005-08-12 | Special | PDF ↗ |
| K051518 | UNITY NETWORK ID | Ge Medical Systems Information Technologies | 2005-07-08 | Special | PDF ↗ |
| K051608 | STAR 50 MONITORING SYSTEM | Larsen & Toubro Limited | 2005-06-29 | Traditional | PDF ↗ |
| K042981 | HYPERQ SYSTEM | Biological Signal Processing, Ltd. | 2005-03-10 | Traditional | PDF ↗ |
| K043370 | PLANET 50 MONITORING SYSTEM | Larsen & Toubro Limited | 2005-02-15 | Traditional | PDF ↗ |
| K043368 | VITELCARE TURTLE, MODEL 400 | Visual Telecommunications Network, Inc. | 2005-02-01 | Special | PDF ↗ |
| K043348 | MODIFICATION TO PM-8000 PATIENT MONITOR | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005-01-06 | Special | PDF ↗ |
| K041918 | INTEGRATED PATIENT MONITORING SYSTEM | Invivo Research, Inc. | 2004-10-15 | Traditional | PDF ↗ |
| K042560 | STELLAR 404 MONITORING SYSTEM | Larsen & Toubro Limited | 2004-10-06 | Traditional | PDF ↗ |
| K042569 | 8600 VITAL SIGNS MONITOR | Criticare Systems, Inc. | 2004-09-29 | Special | PDF ↗ |
| K040915 | MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M | Invivo Research, Inc. | 2004-09-22 | Traditional | PDF ↗ |
| K041942 | M2376A DEVICELINK SYSTEM | Phillips Medical Systems | 2004-07-23 | Special | PDF ↗ |
| K041907 | TRIO MONITOR | Datascope Corp. | 2004-07-23 | Abbreviated | PDF ↗ |
| K041376 | C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A | Analogic Corp. | 2004-07-20 | Abbreviated | PDF ↗ |
| K040969 | POISE DATAENGINE | Poise Technology Corporation | 2004-06-08 | Traditional | PDF ↗ |
| K040559 | MODIFICATION TO UNITY NETWORK ID | Ge Medical Systems Information Technologies | 2004-06-04 | Special | PDF ↗ |
| K041401 | MODIFICATION TO M2376A DEVICELINK SYSTEM | Philips Medical Systems | 2004-06-04 | Special | PDF ↗ |
| K033133 | TELECARE D.R. SERVER SOFTWARE SYSTEM | Healthcare Vision, Inc. | 2004-04-13 | Traditional | PDF ↗ |
| K033378 | VITAL SIGNS MONITOR, PROPAQ LT | Welch Allyn Protocol, Inc. | 2004-03-01 | Traditional | PDF ↗ |
| K033988 | GOLDWAY UT4000A VITAL SIGNS MONITOR | Goldway (Us), Inc. | 2004-02-25 | Traditional | PDF ↗ |
| K033030 | CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM | Witt Biomedical Corp | 2004-02-24 | Traditional | PDF ↗ |
| K032338 | TRIO MONITOR MODEL 0998-00-0600 | Datascope Corp. | 2004-02-11 | Abbreviated | PDF ↗ |
| K033672 | MODIFICATION TO UNITY NETWORK ID | Ge Medical Systems Information Technologies | 2003-12-18 | Special | PDF ↗ |
| K033680 | M2376A PHILIPS DEVICE LINK SYSTEM | Philips Medical Systems | 2003-12-11 | Special | PDF ↗ |
| K032871 | PLANET MONITORING SYSTEM | Larsen & Toubro Limited | 2003-11-10 | Traditional | PDF ↗ |
| K032867 | STAR (LUNAR SERIES) MONITORING SYSTEM | Larsen & Toubro Limited | 2003-11-10 | Traditional | PDF ↗ |
| K030419 | VITERION 100 TELEHEALTH MONITOR | Viterion Telehealthcare, LLC | 2003-11-06 | Traditional | PDF ↗ |
| K033283 | CENTRA VIEW DEVICE LINK SYSTEM | Icu Datasystems, Inc. | 2003-10-27 | Traditional | PDF ↗ |
| K031863 | CARESTATION 126S VIDEOPHONE | Motion Media Technology, Inc. | 2003-10-10 | Traditional | PDF ↗ |
| K032749 | BEDSIDE MONITOR, MODEL OPV-1500 | Nihon Kohden America, Inc. | 2003-09-16 | Special | PDF ↗ |
| K032142 | DATACAPTOR | Capsule Technologie | 2003-08-08 | Special | PDF ↗ |
| K023195 | MAGLIFE C/MAGLIFE C PLUS | Schiller Medical S.A. | 2003-06-03 | Abbreviated | PDF ↗ |
| K021154 | GOLDWAY PATIENT MONITOR, MODEL # UT4000F | Goldway Us, Inc. | 2003-04-11 | Traditional | PDF ↗ |
| K030731 | M2376A DEVICELINK SYSTEM | Philips Medical Systems, Inc. | 2003-03-21 | Special | PDF ↗ |
| K021454 | UNITY NETWORK ID | General Electric Medical Systems Information Techn | 2002-10-01 | Traditional | PDF ↗ |
| K022920 | M2376A DEVICELINK SYSTEM | Philips Medical Systems | 2002-09-17 | Special | PDF ↗ |
| K022537 | PRESS-MATE PM-2100 VITAL SIGN MONITOR | Colin Medical Instruments Corp. | 2002-09-13 | Traditional | PDF ↗ |
| K014255 | DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400 | Ge Medical Systems Information Technologies | 2002-07-02 | Traditional | PDF ↗ |
| K021912 | M2376 DEVICELINK SYSTEM | Philips Medical Systems, Inc. | 2002-06-24 | Special | PDF ↗ |
| K021435 | DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N | Ge Medical Systems Information Technologies | 2002-05-22 | Special | PDF ↗ |
| K021347 | MODIFICATION TO M2376A DEVICELINK SYSTEM | Philips Medical Systems | 2002-05-07 | Special | PDF ↗ |
| K020494 | MODIFICATION TO M2376A DEVICELINK SYSTEM | Philips Medical Systems, Inc. | 2002-02-21 | Special | PDF ↗ |
| K020197 | MODIFICATION TO DATACAPTOR | Capsule Technologie | 2002-02-21 | Special | PDF ↗ |
| K020022 | DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410 | Ge Medical Systems Information Technologies | 2002-02-01 | Special | PDF ↗ |
| K012349 | METAVISION CLINICAL INFORMATION SYSTEM | Imdsoft, Ltd. | 2002-01-29 | Traditional | PDF ↗ |
| K014181 | M2376A DEVICELINK SYSTEM, MODEL M2376A | Philips Medical Systems, Inc. | 2002-01-15 | Special | PDF ↗ |
| K013019 | DATACAPTOR | Capsule Technologie | 2001-12-18 | Traditional | PDF ↗ |
| K013470 | MODIFICATION TO M2376A DEVICELINK SYSTEM | Philips Medical Systems, Inc. | 2001-11-14 | Special | PDF ↗ |
| K010732 | VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM) | Telemedic Systems, Inc. | 2001-09-27 | Traditional | PDF ↗ |
| K010424 | NEXAN SYSTEM, MODEL NX-301 | Nexan, Ltd. | 2001-09-04 | Traditional | PDF ↗ |
| K012059 | 8100/8500 VITAL SIGNS MONITOR | Criticare Systems, Inc. | 2001-08-01 | Special | PDF ↗ |
| K012094 | MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A | Agilent Technologies, Inc. | 2001-07-20 | Special | PDF ↗ |
| K003999 | AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010 | American Telecare, Inc. | 2001-06-28 | Traditional | PDF ↗ |
| K010770 | BCI ADVISOR VITAL SIGNS MONITOR (9200) | Bci, Inc. | 2001-06-12 | Traditional | PDF ↗ |
| K011578 | M2376A DEVICELINK SYSTEM, MODEL M2376A | Agilent Technologies, Inc. | 2001-06-08 | Special | PDF ↗ |
| K004050 | PANASONIC TELE-HOMECARE SYSTEM | Matsushita Electric Industrial Co., Ltd. | 2001-03-15 | Traditional | PDF ↗ |
| K010453 | M2376A DEVICELINK SYSTEM | Agilent Technologies, Inc. | 2001-03-02 | Special | PDF ↗ |
| K010342 | M2376A DEVICELINK SYSTEM, MODEL M2376A | Agilent Technologies, Inc. | 2001-02-14 | Special | PDF ↗ |
| K010048 | M2376A DEVICELINK SYSTEM | Agilent Technologies, Inc. | 2001-02-01 | Traditional | PDF ↗ |
| K003622 | M2376A DEVICELINK SYSTEM, MODEL M2376A | Agilent Technologies, Inc. | 2000-12-18 | Special | PDF ↗ |
| K000404 | PC ECG 1200 | Norav Medical , Ltd. | 2000-11-22 | Traditional | PDF ↗ |
| K003107 | M2376A DEVICELINK SYSTEM | Agilent Technologies, Inc. | 2000-10-19 | Special | PDF ↗ |
| K002967 | M2376A DEVICELINK SYSTEM, MODEL M2376A | Agilent Technologies, Inc. | 2000-10-18 | Special | PDF ↗ |
| K002030 | OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES | Invivo Research, Inc. | 2000-09-26 | Traditional | PDF ↗ |
Product code MWI · Class II · Cardiovascular. Data: openFDA.