FDA Product Code
FDA Product Code DRT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2300
510(k) Clearances — 340 records · page 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K901031 | PCI MODEL 2041-PC TELEMETRY MONITOR | Accucore, Inc. | 1990-05-17 | Traditional | PDF ↗ |
| K896700 | TYPE 9140/NEO | S & W Medico Teknik | 1990-04-20 | Traditional | PDF ↗ |
| K896699 | TYPE 9040/NEO | S & W Medico Teknik | 1990-04-20 | Traditional | PDF ↗ |
| K901034 | MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL | Nihon Kohden America, Inc. | 1990-04-19 | Traditional | PDF ↗ |
| K900032 | MODEL M1175A/M1176A WITH ST SEGMENT MONITORING | Hewlett-Packard Co. | 1990-04-10 | Traditional | PDF ↗ |
| K895801 | MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM | Marquette Electronics, Inc. | 1990-04-04 | Traditional | PDF ↗ |
| K895534 | BIOLOG | Micromedical | 1990-03-19 | Traditional | PDF ↗ |
| K897080 | CARDIOCAP(TM) CT-104 MONITOR | Datex Division Instrumentarium Corp. | 1990-03-06 | Traditional | PDF ↗ |
| K885085 | ERGOMED 840/ERGOMED 840L | Burdick Corp. | 1989-10-03 | Traditional | PDF ↗ |
| K894700 | TYPE PDU/CDU 9040 (SYSTEM ATHENA) | S & W Medico Teknik | 1989-10-02 | Traditional | PDF ↗ |
| K893405 | MODEL DS-504 DYNASCOPE PATIENT MONITOR | Fukuda Denshi USA, Inc. | 1989-10-02 | Traditional | PDF ↗ |
| K894699 | TYPE 9140 (SYSTEM ATHENA) | S & W Medico Teknik | 1989-10-02 | Traditional | PDF ↗ |
| K894919 | NR5000 E.C.G. AND PULSE OXIMETER MONITOR | Nirad , Ltd. | 1989-09-18 | Traditional | PDF ↗ |
| K892795 | PULSE TIME PRODUCTS LIMITED, PM-3 | Pulse Time Products, Ltd. | 1989-08-25 | Traditional | PDF ↗ |
| K892794 | PULSE TIME PRODUCTS LIMITED, PM-2 | Pulse Time Products, Ltd. | 1989-08-25 | Traditional | PDF ↗ |
| K892066 | HORIZON CENTRAL STATION | Mennen Medical, Inc. | 1989-06-22 | Traditional | PDF ↗ |
| K890876 | BP-8800 BLOOD PRESSURE MONITOR | Colin Medical Instruments Corp. | 1989-06-22 | Traditional | PDF ↗ |
| K892006 | HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S | Healthdyne, Inc. | 1989-05-23 | Traditional | PDF ↗ |
| K884804 | THE COACH | Promark, Inc. | 1989-05-19 | Traditional | PDF ↗ |
| K884117 | TYPE 9210 ECG SYSTEM ATHENA | S & W Medico Teknik | 1989-04-26 | Traditional | PDF ↗ |
| K884455 | MODEL 702 ECG/RESPIRATION/TEMPERATURE | Ivy Biomedical Systems, Inc. | 1989-03-09 | Traditional | PDF ↗ |
| K884096 | PATIENT MONITOR MODEL 701 | Ivy Biomedical Systems, Inc. | 1989-02-23 | Traditional | PDF ↗ |
| K884645 | PATIENT MONITOR RIGEL MODEL MULTICARE 429 | Rigel Medical Electronics, Inc. | 1989-02-02 | Traditional | PDF ↗ |
| K882609 | MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM | Waltham Div. Hewlett Packard | 1989-01-19 | Traditional | PDF ↗ |
| K883109 | MINIMON 7136B PATIENT MONITOR | Kontron, Inc. | 1989-01-17 | Traditional | PDF ↗ |
| K883069 | MINIMON 7134B PATIENT MONITOR | Kontron Instruments, Inc. | 1989-01-17 | Traditional | PDF ↗ |
| K884320 | PROPAQ 106(TM) | Protocol Systems, Inc. | 1988-12-27 | Traditional | PDF ↗ |
| K875160 | RIGEL MODEL MULTICARE 409 | Rigel Medical Electronics, Inc. | 1988-06-28 | Traditional | PDF ↗ |
| K874148 | MONITRON SYSTEM | American Health Products, Inc. | 1988-06-15 | Traditional | PDF ↗ |
| K880498 | RM-301 PATIENT MONITOR | Ppg Industries, Inc. | 1988-05-13 | Traditional | PDF ↗ |
| K880066 | MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR | Ivy Biomedical Systems, Inc. | 1988-03-22 | Traditional | PDF ↗ |
| K874319 | MONITOR, ELECTROGRAPHIC | Medac, Inc. | 1988-03-07 | Traditional | PDF ↗ |
| K874844 | CARE TELSTAT MODELS: MP 5010 AND MP 5020 | Care Systems, Inc. | 1988-02-09 | Traditional | PDF ↗ |
| K874695 | HEALTHDYNE APNEA/HEART MONITOR, MODEL 900 | Healthdyne, Inc. | 1988-01-29 | Traditional | PDF ↗ |
| K872354 | SERIES 2000 BEDSIDE PATIENT MONITOR | Marquette Electronics, Inc. | 1987-07-21 | Traditional | PDF ↗ |
| K872249 | SIRECUST MODEL 960 AND 961 PATIENT MONITORING | Medical Electronics Laboratories, Inc. | 1987-07-21 | Traditional | PDF ↗ |
| K872443 | COMPANION 50 REGULATOR/FLOWMETER | Puritan Bennett Corp. | 1987-07-21 | Traditional | PDF ↗ |
| K871149 | DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER | Iontec Corp. | 1987-06-05 | Traditional | PDF ↗ |
| K864748 | PM-8 HEART RATE MONITOR | Pulse Time Products, Ltd. | 1987-03-20 | Traditional | PDF ↗ |
| K863466 | M700 STRESS MONITOR | Kone Instruments, Inc. | 1986-12-22 | Traditional | PDF ↗ |
| K863494 | NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 | Advantage Medical Systems, Inc. | 1986-12-22 | Traditional | PDF ↗ |
| K862463 | LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC | Nihon Kohden America, Inc. | 1986-12-05 | Traditional | PDF ↗ |
| K850449 | DIGITAL PULSE METER HRM-100E & ETC. | Sanyo Electric, Inc. | 1986-12-04 | Traditional | PDF ↗ |
| K863534 | LIFE-WATCH MONITOR LT-8 | Computerized Medical Systems, Inc. | 1986-11-21 | Traditional | PDF ↗ |
| K861621 | CARDIAN II CR45A | Cardiac Recorders, Ltd. | 1986-09-12 | Traditional | PDF ↗ |
| K854847 | PHYSIO-DYNE ECG/HR 3 | Physio-Dyne Industrument Corp. | 1986-06-16 | Traditional | PDF ↗ |
| K854491 | ERG 550 ERGOMETER BICYCLE | Robert Bosch Corp. | 1986-06-16 | Traditional | PDF ↗ |
| K854492 | ERG 551 ERGOMETER, BICYCLE | Robert Bosch Corp. | 1986-06-16 | Traditional | PDF ↗ |
| K854493 | ERG 555 COUCH ERGOMETER | Robert Bosch Corp. | 1986-06-16 | Traditional | PDF ↗ |
| K853953 | CARDIOCAP MONITOR | Instrumentarium Corp. | 1986-06-02 | Traditional | PDF ↗ |
| K854597 | VICKERS MEDICAL MODEL 271 HEART RATE MONITOR | Vickers , Ltd. | 1986-05-09 | Traditional | PDF ↗ |
| K854639 | BIOMECCA CENTRAL CS1 | Biomecca Australia , Ltd. | 1986-04-17 | Traditional | PDF ↗ |
| K855125 | PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM | Honeywell, Inc. | 1986-03-26 | Traditional | PDF ↗ |
| K854198 | PE-3000 PULSE RATE MONITOR | Quantum Life Systems, Inc. | 1986-03-13 | Traditional | PDF ↗ |
| K853318 | PATIENT MONITOR PB240 | Puritan Bennett Corp. | 1986-03-11 | Traditional | PDF ↗ |
| K854881 | SIRECUST 341 AND 341R | Siemens Medical Solutions USA, Inc. | 1986-03-11 | Traditional | PDF ↗ |
| K853757 | MOLDTEC STIMULATOR | Moldtec, Inc. | 1986-02-28 | Traditional | PDF ↗ |
| K854041 | CD-100 CARDIAC MONITOR | Cardio Display Corp. | 1986-01-07 | Traditional | PDF ↗ |
| K853673 | CARDIORATER CR 51 | Cardiac Recorders, Ltd. | 1985-12-11 | Traditional | PDF ↗ |
| K852910 | CARDIORATER CR7 | Cardiac Recorders, Ltd. | 1985-11-19 | Traditional | PDF ↗ |
| K852887 | CR5 CARDIAC MONITOR | Cardiac Recorders, Ltd. | 1985-11-14 | Traditional | PDF ↗ |
| K851916 | VSM MODELS A & B | Physio-Control Corp. | 1985-08-19 | Traditional | PDF ↗ |
| K840717 | ECS 502 | Robert Bosch Corp. | 1985-08-19 | Traditional | PDF ↗ |
| K851335 | COACH TM- THE AEROBIC FITNESS MONITOR | Biotechnology, Inc. | 1985-07-24 | Traditional | PDF ↗ |
| K843533 | CARDIAC EVENT RECORDER | Cryo2 Corp. | 1985-06-28 | Traditional | PDF ↗ |
| K842817 | MODEL 78353B | Hewlett-Packard Co. | 1985-06-06 | Traditional | PDF ↗ |
| K850619 | BEDSIDE PATIENT MONITOR W/MODULES | Midwest Analog & Digital, Inc. | 1985-06-06 | Traditional | PDF ↗ |
| K851325 | MICROCOR ECG MONITOR | Microcor, Inc. | 1985-05-21 | Traditional | PDF ↗ |
| K844731 | KONTRON SUPERMON 7210 PATIENT MONITOR | Kontron Instruments, Inc. | 1985-05-16 | Traditional | PDF ↗ |
| K850135 | MEDWATCH 400 CARDIAC CENTRAL NURSES STATION | Medwatch Systems, Inc. | 1985-05-16 | Traditional | PDF ↗ |
| K850880 | HORIZON 1000 CARDIAC MONITOR | Mennen Medical, Inc. | 1985-04-25 | Traditional | PDF ↗ |
| K850407 | NEONATAL MONITOR 309 | Rigel Medical Electronics, Inc. | 1985-04-18 | Traditional | PDF ↗ |
| K844187 | SIEMENS SIRECUST 404N NEONATAL MONITOR | Siemens Medical Solutions USA, Inc. | 1985-04-11 | Traditional | PDF ↗ |
| K844215 | KONTRON MINIMON 7134 PATIENT MONITOR | Kontron Instruments, Inc. | 1985-04-04 | Traditional | PDF ↗ |
| K844733 | KONTRON MINIMON 7131 PATIENT MONITOR | Kontron Instruments, Inc. | 1985-03-27 | Traditional | PDF ↗ |
| K844732 | KONTRON MINIMON 7132 PATIENT MONITOR | Kontron Instruments, Inc. | 1985-03-27 | Traditional | PDF ↗ |
| K850155 | ECG PATIENT MONITOR 302 | Rigel Medical Electronics, Inc. | 1985-03-01 | Traditional | PDF ↗ |
| K842037 | LS 5 | Life Science Instrumentation, Inc. | 1985-03-01 | Traditional | PDF ↗ |
| K850156 | ECG PATIENT MONITOR 301 | Rigel Medical Electronics, Inc. | 1985-03-01 | Traditional | PDF ↗ |
| K850114 | C/PES 9201, ECG STRESS TESTING SYS | Gould, Inc. | 1985-02-22 | Traditional | PDF ↗ |
| K850043 | CARDIOGUARD STRESS TEST MONITOR 4002 | Del Mar Avionics | 1985-02-08 | Traditional | PDF ↗ |
| K850113 | C/PES 9103, ECG STRESS TESTING SYSTEM | Gould, Inc. | 1985-02-08 | Traditional | PDF ↗ |
| K844888 | SPACELABS SERIES 600 PATIENT MONITORS | Spacelabs, Inc. | 1985-02-01 | Traditional | PDF ↗ |
| K844911 | ARRHYTHMIA CENTRAL-OGP-7201 | Nihon Kohden America, Inc. | 1985-01-18 | Traditional | PDF ↗ |
| K842236 | PATIENT MONITOR 78354A | Hewlett-Packard Co. | 1985-01-18 | Traditional | PDF ↗ |
| K843376 | ECG PATIENT MONITOR | Rigel Medical Electronics, Inc. | 1984-12-27 | Traditional | PDF ↗ |
| K842582 | CARE 5000 CENTRAL MONITOR MS5220 ETC. | Care Monitoring Systems | 1984-12-11 | Traditional | PDF ↗ |
| K844348 | DYNASCOPE MONITOR DS-800 | Fukuda Denshi USA, Inc. | 1984-12-04 | Traditional | PDF ↗ |
| K840523 | SERVOMED PULSE AMPLIFIER MODULE-206- | Litton Medical Electronics | 1984-10-29 | Traditional | PDF ↗ |
| K833689 | DIASCOPE 2 | S & W Medico Teknik | 1984-10-26 | Traditional | PDF ↗ |
| K840524 | SERVOMED BASIC BEDSIDE UNIT SMV 110TP | Litton Medical Electronics | 1984-10-26 | Traditional | PDF ↗ |
| K841363 | HEART RATE/RESPIRATION SIMULATOR 8310 | Aequitron Medical, Inc. | 1984-10-02 | Traditional | PDF ↗ |
| K840832 | SERVOMED OXCARDIORE SPIROGRAPH 324/111 | Litton Medical Electronics | 1984-09-20 | Traditional | PDF ↗ |
| K842462 | HOLTER SCREENING MONITOR HS-221 | Advantage Medical Systems, Inc. | 1984-09-11 | Traditional | PDF ↗ |
| K833594 | FUKUDA DENSHI FX-302 AUTO/THREE CHAN | Brentwood Instruments, Inc. | 1984-09-11 | Traditional | PDF ↗ |
| K841499 | LIFESCOPE II | Nihon Kohden America, Inc. | 1984-08-28 | Traditional | PDF ↗ |
| K841502 | LIFESCOPE 6 OEC-6105 | Nihon Kohden America, Inc. | 1984-08-28 | Traditional | PDF ↗ |
| K841501 | LIFESCOPE 6 OEC-6102 | Nihon Kohden America, Inc. | 1984-08-28 | Traditional | PDF ↗ |
| K840055 | DYNASCOPE SERIES | Fukuda Denshi USA, Inc. | 1984-08-22 | Traditional | PDF ↗ |
| K842321 | AIR SHIELDS AS461 MONITORING SYS | Air-Shields, Inc. | 1984-08-03 | Traditional | PDF ↗ |
Product code DRT · Class II · Cardiovascular. Data: openFDA.