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 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K152341 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | 2015-12-14 | Traditional | PDF ↗ |
| K150869 | Checkme Pro Health Monitor | Viatom Technology Co., Ltd. | 2015-12-10 | Traditional | PDF ↗ |
| K151715 | T3 Software | Etiometry, Inc. | 2015-10-29 | Traditional | PDF ↗ |
| K152124 | Tempus IC2 | Remote Diagnostics Technologies, Ltd. | 2015-10-28 | Traditional | PDF ↗ |
| K151071 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie Sas | 2015-09-17 | Traditional | PDF ↗ |
| K150512 | STAR 90 | Skanray Technologies Pvt, Ltd. | 2015-06-17 | Traditional | PDF ↗ |
| K143304 | Sickbay Clinical Platform | Medical Informatics Corp | 2015-05-26 | Traditional | PDF ↗ |
| K150691 | Datalys Multi-Parameter Patient Monitor | Lutech Industries, Inc. | 2015-05-15 | Traditional | PDF ↗ |
| K150620 | 740 SELECT | Cas Medical Systems, Inc. | 2015-05-08 | Traditional | PDF ↗ |
| K142032 | MRI PATIENT MONITORING SYSTEM TESLA M3 | Mipm Mammendorfer Institut Fur Physik Und Medizin | 2015-05-07 | Traditional | PDF ↗ |
| K142087 | COVA MONITORING SYSTEM | Tosense, Inc. | 2015-05-01 | Traditional | PDF ↗ |
| K150361 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | 2015-04-30 | Special | PDF ↗ |
| K143372 | AWARE | Ambient Clinical Analytics | 2015-04-02 | Traditional | PDF ↗ |
| K142732 | T3 Software | Etiometry, Inc. | 2015-03-04 | Traditional | PDF ↗ |
| K142244 | CLEO PATIENT MONITOR | Infinium Medical | 2015-02-06 | Traditional | PDF ↗ |
| K143751 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2015-01-23 | Traditional | PDF ↗ |
| K142106 | DECISIO HEALTH PATIENT DASHBOARD | Decisio Health, Inc. | 2015-01-18 | Traditional | PDF ↗ |
| K142840 | Unity Network ID | GE Healthcare | 2015-01-07 | Special | PDF ↗ |
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core | Welch Allyn, Inc. | 2014-12-19 | Traditional | PDF ↗ |
| K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014-11-25 | Traditional | PDF ↗ |
| K133810 | VC150 VITAL SIGNS MONITOR | Innokas Yhtyma | 2014-10-30 | Traditional | PDF ↗ |
| K134014 | TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) | Remote Diagnostic Technologies , Ltd. | 2014-08-12 | Traditional | PDF ↗ |
| K140188 | MASIMO ROOT MONITORING SYSTEM | Masimo Corporation | 2014-06-25 | Traditional | PDF ↗ |
| K140430 | 740 SELECT | Cas Medical Systems, Inc. | 2014-06-13 | Traditional | PDF ↗ |
| K131762 | HANDHELD MONITOR | Guangdong Biolight Meditech Co., Ltd. | 2014-06-06 | Traditional | PDF ↗ |
| K133988 | TEMPUS PRO EXTENDED FEATURES | Remote Diagnostic Technologies , Ltd. | 2014-05-16 | Abbreviated | PDF ↗ |
| K132037 | VITAL SIGNS MONITOR | Mindray North America | 2014-05-16 | Abbreviated | PDF ↗ |
| K132038 | ACCUTORR 7 VITAL SIGNS MONITOR | Mindray North America | 2014-05-02 | Abbreviated | PDF ↗ |
| K140339 | VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM | Covidien | 2014-04-10 | Traditional | PDF ↗ |
| K132229 | OMNI PATENT MONITORS | Infinium Medical | 2014-02-21 | Traditional | PDF ↗ |
| K131898 | A SERIES AND Q SERIES PATIENT MONITORS | Guangdong Biolight Meditech Co., Ltd. | 2014-02-18 | Traditional | PDF ↗ |
| K133450 | AIRSTRIP REMOTE PATIENT MONITORING | Airstrip Technologies, LP | 2014-02-14 | Special | PDF ↗ |
| K133394 | AIRSTRIP REMOTE PATIENT MONITORING | Airstrip Technologies, LP | 2014-02-06 | Traditional | PDF ↗ |
| K132807 | MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) | Welch Allyn, Inc. | 2014-01-31 | Special | PDF ↗ |
| K133586 | VISI MOBILE MONITIORING SYSTEM | Sotera Wireless, Inc. | 2013-12-18 | Special | PDF ↗ |
| K131497 | MCKESSON CARDIOLOGY HEMO | Mckesson Israel , Ltd. | 2013-12-05 | Traditional | PDF ↗ |
| K132604 | VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM | Covidien | 2013-12-04 | Special | PDF ↗ |
| K132033 | BM3/BM3 PLUS | Noblitt & Rueland | 2013-12-04 | Traditional | PDF ↗ |
| K132808 | VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR | Welch Allyn, Inc. | 2013-11-20 | Special | PDF ↗ |
| K130709 | VISI MOBILE MONITORING SYSTEM | Sotera Wireless, Inc. | 2013-10-07 | Traditional | PDF ↗ |
| K123711 | PATIENT MONITOR | Shenzhen Creative Industry Co., Ltd. | 2013-10-01 | Traditional | PDF ↗ |
| K132359 | MRI PATIENT MONITORING SYSTEM | Invivo Corporation | 2013-08-30 | Special | PDF ↗ |
| K130740 | NIGHTINGALE MONITORING SYSTEM | Zoe Medical, Inc. | 2013-07-23 | Traditional | PDF ↗ |
| K131382 | EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL | Invivo Corporation | 2013-07-15 | Special | PDF ↗ |
| K131786 | AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER | Airstrip Technologies, LP | 2013-07-03 | Traditional | PDF ↗ |
| K124038 | BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS) | Bedside Clinical Systems, Inc. | 2013-06-21 | Traditional | PDF ↗ |
| K130773 | TEMPUS PRO PATIENT MONITOR | Remote Diagnostic Technologies , Ltd. | 2013-06-05 | Traditional | PDF ↗ |
| K130411 | 740 SELECT | Cas Medical Systems, Inc. | 2013-05-29 | Traditional | PDF ↗ |
| K130796 | VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM | Covidien | 2013-05-09 | Traditional | PDF ↗ |
| K130957 | WVSM (WIRLESS VITAL SIGNS MONITOR) | Athena Gtx | 2013-04-30 | Special | PDF ↗ |
| K130056 | PATIENT MONITOR | Ld Technology, LLC | 2013-04-11 | Traditional | PDF ↗ |
| K130234 | NUVON VITALS CHARTING SYSTEM | Nuvon, Inc. | 2013-03-13 | Traditional | PDF ↗ |
| K123002 | VITAL SYNC SYSTEM | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2013-02-27 | Traditional | PDF ↗ |
| K124061 | MRI PATIENT MONITORING SYSTEM (MODEL 865214) | Invivo Corporation | 2013-02-22 | Special | PDF ↗ |
| K112877 | COMEN MULTI-PARAMETER PATIENT MONITOR | Goldway (Us), Inc. | 2012-11-07 | Traditional | PDF ↗ |
| K122133 | AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING | Airstrip Technologies, LP | 2012-10-02 | Special | PDF ↗ |
| K122036 | VISI MOBILE MONITORING SYSTEM | Sotera Wireless, Inc. | 2012-08-15 | Traditional | PDF ↗ |
| K121013 | CONNEX VITAL SIGNS MONITOR 6000 SERIES | Welch Allyn, Inc. | 2012-07-26 | Special | PDF ↗ |
| K121871 | AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING | Airstrip Technologies, LP | 2012-07-03 | Traditional | PDF ↗ |
| K120193 | ANY VIEW PATIENT MONITORS | Guangdong Biolight Meditech Co., Ltd. | 2012-06-29 | Traditional | PDF ↗ |
| K113835 | DATACAPTOR SYSTEM | Capsule Tech, Inc. | 2012-06-27 | Traditional | PDF ↗ |
| K121424 | EXPRESSION INFORMATION PORTAL | Invivo Corporation | 2012-06-13 | Special | PDF ↗ |
| K113833 | VITAL SIGNS MONITOR | Guangdong Biolight Meditech Co., Ltd. | 2012-05-01 | Traditional | PDF ↗ |
| K112478 | VISI MOBILE MONITORING SYSTEM | Sotera Wireless, Inc. | 2012-03-22 | Traditional | PDF ↗ |
| K120343 | CONNEX WORKSTATION | Welch Allyn, Inc. | 2012-02-24 | Special | PDF ↗ |
| K113183 | PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 | Shanghai 3f Electronics Co, Ltd. | 2012-02-09 | Abbreviated | PDF ↗ |
| K113165 | MINI-MEDIC | Athena Gtx | 2012-02-02 | Traditional | PDF ↗ |
| K113105 | TEMPUSIC PATIENT MONITOR | Remote Diagnostic Technologies , Ltd. | 2011-12-15 | Abbreviated | PDF ↗ |
| K112687 | CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES | Welch Allyn, Inc. | 2011-11-22 | Special | PDF ↗ |
| K110463 | PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) | Norav Medical , Ltd. | 2011-11-10 | Special | PDF ↗ |
| K112329 | OMNI PATIENT MONITOR | Infinium Medical | 2011-09-08 | Special | PDF ↗ |
| K112235 | AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING | Airstrip Technologies, LP | 2011-08-26 | Traditional | PDF ↗ |
| K103737 | OMNI II PATIENT MONITOR | Infinium Medical | 2011-06-02 | Special | PDF ↗ |
| K110516 | CONNEX VITAL SIGNS MONITOR 6000 SERIES | Welch Allyn, Inc. | 2011-06-01 | Special | PDF ↗ |
| K100424 | DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS | Danmedical Limited | 2011-03-21 | Traditional | PDF ↗ |
| K103686 | STAR 50 N | Larsen & Toubro Limited | 2011-03-15 | Traditional | PDF ↗ |
| K103763 | STELLAR 300 | Larsen & Toubro Limited | 2011-03-11 | Traditional | PDF ↗ |
| K110503 | AIRSTRIP REMOTE PATIENT MONITORING (RPM) | Airstrip Technologies, LP | 2011-03-10 | Special | PDF ↗ |
| K103432 | UNITY NETWORK ID | Ge Medical Systems Information Technologies, Inc. | 2010-12-17 | Special | PDF ↗ |
| K102579 | HYPERQ AD-100 SYSTEM | Biological Signal Processing, Ltd. | 2010-12-02 | Special | PDF ↗ |
| K103268 | OMNI EXPRESS | Infinium Medical | 2010-11-23 | Special | PDF ↗ |
| K101571 | XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS | Witt Biomedical Corp | 2010-10-26 | Traditional | PDF ↗ |
| K102135 | VECTOR EVENT GRID ARCHITECTURE (VEGA) SYSTEM | Nuvon, Inc. | 2010-10-22 | Traditional | PDF ↗ |
| K102426 | CARESCAPE MODEL V100 VITAL SIGNS MONITOR | Ge Medical Systems Information Technologies | 2010-10-20 | Special | PDF ↗ |
| K101052 | OMNI III PATIENT MONITOR | Infinium Medical | 2010-08-11 | Traditional | PDF ↗ |
| K100133 | AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1 | Airstrip Technologies, LP | 2010-07-23 | Traditional | PDF ↗ |
| K101674 | WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0 | Athena Gtx | 2010-07-21 | Traditional | PDF ↗ |
| K100740 | MD2000B VITAL SIGN MONITOR, MODEL MD2000B | Beijing Choice Electronic Technololgy Co., Ltd. | 2010-07-09 | Traditional | PDF ↗ |
| K101259 | V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002 | Taidoc Technology Corporation | 2010-06-17 | Traditional | PDF ↗ |
| K101127 | PATIENT MONITOR, MODEL PM50 | Contec Medical System Co., Ltd. | 2010-06-11 | Traditional | PDF ↗ |
| K101445 | VITAL SIGNS MONITOR-VSM 6000 SERIES | Welch Allyn, Inc. | 2010-06-08 | Abbreviated | PDF ↗ |
| K101264 | TEMPUS IC PROFESSIONAL PATIENT MONITOR | Remote Diagnostic Technologies , Ltd. | 2010-05-11 | Traditional | PDF ↗ |
| K093422 | VITAL SYNC MODEL 5000 SERIES | Somanetics Corp. | 2010-04-29 | Traditional | PDF ↗ |
| K093017 | STELLAR 300 | Larsen & Toubro Limited | 2010-04-29 | Traditional | PDF ↗ |
| K100394 | MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A | Shanghai 3f Electronics Co, Ltd. | 2010-04-15 | Traditional | PDF ↗ |
| K093177 | INTELLIBRIDGE SYSTEM | Philips Medical Systems | 2009-12-18 | Special | PDF ↗ |
| K090785 | MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 | Invivo Corp. | 2009-12-15 | Special | PDF ↗ |
| K092153 | SKYLINE 55, MODEL VER 1 | Larsen & Toubro Limited | 2009-11-20 | Traditional | PDF ↗ |
| K083229 | E.S TECK ( ELECTRO SENSOR TECK) | Ld Technology, LLC | 2009-02-23 | Traditional | PDF ↗ |
| K082887 | PM-1000F+PATIENT MONITOR | Advanced Instrumentations, Inc. | 2009-01-16 | Traditional | PDF ↗ |
Product code MWI · Class II · Cardiovascular. Data: openFDA.