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 3 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K840521 | SERVOMED DIGITAL DISPLAY MODULE | Litton Medical Electronics | 1984-06-01 | Traditional | PDF ↗ |
| K834600 | RECOMB ECG PREAMPLIFIER/206 069 03 | Litton Medical Electronics | 1984-06-01 | Traditional | PDF ↗ |
| K840525 | SERVOMED COMPACT MONITOR SMK 155-1/101 | Litton Medical Electronics | 1984-06-01 | Traditional | PDF ↗ |
| K832250 | SERVOMED BASIC BEDSIDE UNIT SMA 102- | Litton Medical Electronics | 1984-06-01 | Traditional | PDF ↗ |
| K834530 | EXTENSION BOX EB200 | Honeywell, Inc. | 1984-06-01 | Traditional | PDF ↗ |
| K840560 | NEONATAL PHYSIOLOGICAL MONITOR 903 | Novametrix Medical Systems, Inc. | 1984-04-17 | Traditional | PDF ↗ |
| K832095 | SEVOMED COMPACT MONITOR SMK 154- | Litton Medical Electronics | 1984-03-22 | Traditional | PDF ↗ |
| K832025 | SERVOMED COMPACT MONITOR SMK 155-7/101 | Litton Medical Electronics | 1984-03-22 | Traditional | PDF ↗ |
| K840251 | PATIENT MONITOR 78534B | Hewlett-Packard Co. | 1984-02-27 | Traditional | PDF ↗ |
| K833552 | TREND PROCESSOR OPTION FOR #515 NEONAT | Ge Medical Systems Information Technologies | 1984-01-27 | Traditional | PDF ↗ |
| K832724 | ACTIMETER UB-103 | Copal, Inc. | 1983-12-22 | Traditional | PDF ↗ |
| K831164 | PATIENT MONITOR CM 135 | Honeywell, Inc. | 1983-12-01 | Traditional | PDF ↗ |
| K832035 | SERVOMED COMPACT MONITOR SMK 155-9 | Litton Medical Electronics | 1983-11-16 | Traditional | PDF ↗ |
| K832131 | SERVOMED CENTRAL STATION SMV 206 | Litton Medical Electronics | 1983-11-16 | Traditional | PDF ↗ |
| K832021 | SERVOMED COMPACT MONITOR SMK 154-8/101 | Litton Medical Electronics | 1983-11-16 | Traditional | PDF ↗ |
| K831817 | PATIENT MONITOR #RM-100 | Honeywell, Inc. | 1983-10-31 | Traditional | PDF ↗ |
| K832018 | SERVOMED COMPACT MONITOR 181/10105002 | Litton Medical Electronics | 1983-10-31 | Traditional | PDF ↗ |
| K831818 | CENTRAL STATION MONITOR CSM-100 | Honeywell, Inc. | 1983-10-31 | Traditional | PDF ↗ |
| K832026 | SERVOMED BASIC BEDSIDE UNIT SMS 108 W/ | Litton Medical Electronics | 1983-10-26 | Traditional | PDF ↗ |
| K832016 | LME HEART-RATE MONITOR | Litton Medical Electronics | 1983-10-26 | Traditional | PDF ↗ |
| K832024 | SERVOMED BASIC BEDSIDE UNIT - VARIOUS | Litton Medical Electronics | 1983-10-26 | Traditional | PDF ↗ |
| K832041 | SERVOMED STANDARD SMS 104 | Litton Medical Electronics | 1983-10-26 | Traditional | PDF ↗ |
| K831944 | PATIENT MONITOR #78832A | Hewlett-Packard Co. | 1983-10-19 | Traditional | PDF ↗ |
| K831943 | PATIENT MONITOR 788 33A | Hewlett-Packard Co. | 1983-10-19 | Traditional | PDF ↗ |
| K831428 | AS 1740 INTERFACE MODULE | Narco Scientific | 1983-10-14 | Traditional | PDF ↗ |
| K831752 | BIOCHECK PEC-108 PROGRAM-PULSE MONITOR | Biotechnology, Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K831787 | PATIENT MONITOR #78353A | Hewlett-Packard Co. | 1983-09-29 | Traditional | PDF ↗ |
| K831430 | AIR SHIELDS AS-100 MONIORING SYS-AS105 | Narco Scientific | 1983-09-12 | Traditional | PDF ↗ |
| K831578 | PHYSIOLOGICAL MONITOR #902 | Novametrix Medical Systems, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K830916 | VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR | Bib, Inc. | 1983-07-07 | Traditional | PDF ↗ |
| K830885 | GOULD MODEL IM3000-IM3100 BATTERY POWER | Gould, Inc. | 1983-06-22 | Traditional | PDF ↗ |
| K830517 | CENTRAL STATION DISPLAY/RECORDER MATRIX | Marquette Electronics, Inc. | 1983-06-15 | Traditional | PDF ↗ |
| K830587 | VITAL SIGNS MONITOR 2 | Physio-Control Corp. | 1983-06-08 | Traditional | PDF ↗ |
| K823904 | MODEL 515 NEO-TRAK NEONATAL MONITOR | Ge Medical Systems Information Technologies | 1983-05-25 | Traditional | PDF ↗ |
| K830795 | CABINET FOR MULTIPLE FUNCTION BLOCKS | Electronics For Medicine, Inc. | 1983-05-18 | Traditional | PDF ↗ |
| K830779 | PRESSURE FUNCTION BLOCK FOR BLOOD PRESS | Honeywell, Inc. | 1983-05-09 | Traditional | PDF ↗ |
| K830282 | ELECTRONIC EXERCISE #313-PULSE RATE | Walton Manufacturer Co. | 1983-04-14 | Traditional | PDF ↗ |
| K830433 | PATIENT MONITOR 575 | Kone Instruments, Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K830432 | CENTRAL STATION 590 | Kone Instruments, Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K823290 | NEUROMEDICS PACETRON HEART RATE MONITOR | Intermedics, Inc. | 1982-12-30 | Traditional | PDF ↗ |
| K823197 | MODEL 8300 TESTER | Medicon, Inc. | 1982-12-30 | Traditional | PDF ↗ |
| K823312 | CADIO-RESPIRATORY MONITOR #CR-2 | Electromed Intl., Ltd. | 1982-11-30 | Traditional | PDF ↗ |
| K822952 | 560 | Kone Instruments, Inc. | 1982-11-01 | Traditional | PDF ↗ |
| K822876 | MODEL 78534A PATIENT MONITOR | Hewlett-Packard Co. | 1982-10-18 | Traditional | PDF ↗ |
| K822695 | SIGNAL DISTRIBUTION NETWORK #78581A | Hewlett-Packard Co. | 1982-10-15 | Traditional | PDF ↗ |
| K822692 | DIGITAL PULSE METER (73 BWS) #HRM-100E | Sanyo Electric, Inc. | 1982-10-15 | Traditional | PDF ↗ |
| K822615 | LIFE WATCH LSI | Life Science Instrumentation, Inc. | 1982-09-21 | Traditional | PDF ↗ |
| K822389 | LIFE TRACE 40/42 | Life Science Instrumentation, Inc. | 1982-09-21 | Traditional | PDF ↗ |
| K822390 | LIFE TRACE 24 | Life Science Instrumentation, Inc. | 1982-09-21 | Traditional | PDF ↗ |
| K822319 | RE1000 HEART RATE MONITOR | Electronic Monitors, Inc. | 1982-09-14 | Traditional | PDF ↗ |
| K821942 | HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85 | Harvey-Bostwick, Inc. | 1982-08-24 | Traditional | PDF ↗ |
| K822388 | LIFE TRACE 14 | Life Science Instrumentation, Inc. | 1982-08-24 | Traditional | PDF ↗ |
| K821959 | CARDIO-RESPIRATORY MONITOR MODEL CR-1 | Electromed Intl., Ltd. | 1982-07-20 | Traditional | PDF ↗ |
| K821755 | TELCOR 2 | Burdick Corp. | 1982-07-02 | Traditional | PDF ↗ |
| K821720 | PHYSIOLOGICAL DISPLAY SYSTEM, MODEL 1000 | Novametrix Medical Systems, Inc. | 1982-06-25 | Traditional | PDF ↗ |
| K821223 | CR-9 | Life Science Instrumentation, Inc. | 1982-06-17 | Traditional | PDF ↗ |
| K821368 | MODELS 78504A & 78508A PATIENT MON. SYS | Hewlett-Packard Co. | 1982-05-25 | Traditional | PDF ↗ |
| K821015 | CARE MODEL IP 4500 AUTO SCANNERR | Care Monitoring Systems | 1982-05-24 | Traditional | PDF ↗ |
| K820825 | CARDIAC MONITOR - RATE ALARM | Hewlett-Packard Co. | 1982-04-15 | Traditional | PDF ↗ |
| K820745 | DIASCOPE 2 | Puritan Bennett Corp. | 1982-04-01 | Traditional | PDF ↗ |
| K820671 | CM10 CENTRAL MONITORING SYSTEM | Medtel Pty. , Ltd. | 1982-04-01 | Traditional | PDF ↗ |
| K820540 | OLLI 565 | Kone Instruments, Inc. | 1982-04-01 | Traditional | PDF ↗ |
| K820399 | HS20 PORT. OPERATING ROOM MONITOR | Medtel Pty. , Ltd. | 1982-03-22 | Traditional | PDF ↗ |
| K820417 | #506 PORT. VITAL FUNCTIONS NEONATAL MON | Ge Medical Systems Information Technologies | 1982-03-04 | Traditional | PDF ↗ |
| K820416 | #505 PORT. VITAL FUNCTIONS NEONATAL MON | Ge Medical Systems Information Technologies | 1982-03-04 | Traditional | PDF ↗ |
| K820114 | SYSTEM V.HEART RATE/RESPIR. RATE MONIT. | Narco Air-Shields | 1982-02-12 | Traditional | PDF ↗ |
| K813174 | BRADYCARDIA ALARM | Douglas Scientific Products | 1982-01-22 | Traditional | PDF ↗ |
| K813444 | NIHON KOHDEN HEART MONITORS OMP 7101-02 | Nihon Kohden America, Inc. | 1981-12-29 | Traditional | PDF ↗ |
| K812828 | MODEL 2000 MONITOR | Datascope Corp. | 1981-11-16 | Traditional | PDF ↗ |
| K812674 | INFANT CARIDAC MONITOR | Electromed Intl., Ltd. | 1981-10-13 | Traditional | PDF ↗ |
| K812146 | CARDIORATER CR-5 | Life Science Instrumentation, Inc. | 1981-09-25 | Traditional | PDF ↗ |
| K812147 | CARDIORATER CR-7 | Life Science Instrumentation, Inc. | 1981-09-25 | Traditional | PDF ↗ |
| K812144 | CENTERAL MONITOR 360 | Life Science Instrumentation, Inc. | 1981-09-25 | Traditional | PDF ↗ |
| K812145 | CARDIORATER CR-3 | Life Science Instrumentation, Inc. | 1981-09-25 | Traditional | PDF ↗ |
| K812131 | PORTAPULSE | Gavon, Inc. | 1981-09-21 | Traditional | PDF ↗ |
| K811425 | CARDIACMONITORS | Pulse Time Products, Ltd. | 1981-09-16 | Traditional | PDF ↗ |
| K811893 | NOVAMETRIX PHYSIOLOGICAL MONITOR #910 | Novametrix Medical Systems, Inc. | 1981-09-08 | Traditional | PDF ↗ |
| K812271 | CENTRAL STATION MONITOR | Datascope Corp. | 1981-08-31 | Traditional | PDF ↗ |
| K811216 | RESIDENT BEDSIDE MONITOR | Abbott Laboratories | 1981-07-02 | Traditional | PDF ↗ |
| K810755 | SQUINN VITATEK 500 SERIES PHYSIOL. MONI | Vitatek | 1981-04-03 | Traditional | PDF ↗ |
| K803223 | ADVANCMED ELIMINATOR | American Edwards Laboratories | 1981-01-13 | Traditional | PDF ↗ |
| K802782 | THE CRITERION II PACING SYS. MONITOR | Dart Medical Equipment | 1980-11-19 | Traditional | PDF ↗ |
| K802182 | WISCONSIN HEART RATE MONITOR | Lunar Radiation Corp. | 1980-10-31 | Traditional | PDF ↗ |
| K802325 | CRITERION II PACING SYSTEM MONITORS | Dart Medical Equipment | 1980-10-23 | Traditional | PDF ↗ |
| K802204 | CT-1600 DIGITAL PULSE RATE MONITOR | Industrial & Biomedical Sensors Corp. | 1980-10-03 | Traditional | PDF ↗ |
| K800519 | HEARTWATCH | D. Jenkins | 1980-09-26 | Traditional | PDF ↗ |
| K802184 | HS10 PORTABLE OPERATING ROOM MONITOR | Medtel Pty. , Ltd. | 1980-09-26 | Traditional | PDF ↗ |
| K801761 | PDS COMPUTER UNIT/VIDEO TERMINAL | General Electric Co. | 1980-08-20 | Traditional | PDF ↗ |
| K800405 | A-V MINI CLINIC | Instromedix, Inc. | 1980-07-21 | Traditional | PDF ↗ |
| K801515 | ABBY II PATIENT MONITOR OR VITAL SIGNS M | Abbott Medical Electronics Co. | 1980-07-08 | Traditional | PDF ↗ |
| K800243 | D668 & D664 CENTRAL MONITORING SYSTEMS | Medtel Pty. , Ltd. | 1980-04-10 | Traditional | PDF ↗ |
| K800500 | PULSEOMETER | Kirklands Sporting Goods Co. | 1980-04-08 | Traditional | PDF ↗ |
| K792226 | CARDIVAN BLOOD PRESSURE MONITOR | Paramed Technology, Inc. | 1979-12-19 | Traditional | PDF ↗ |
| K792122 | CHRONAEROBIC (CA-1) | Stanford Scientific, Inc. | 1979-11-27 | Traditional | PDF ↗ |
| K792312 | HEART RATE MONITOR MD-1 | Medical Devices, Inc. | 1979-11-21 | Traditional | PDF ↗ |
| K792117 | AIR-SHIELDS HEART RATE MONITOR | Narco Air-Shields | 1979-11-13 | Traditional | PDF ↗ |
| K791862 | HEART RATE COMPUTER | Stanford Assoc., Inc. | 1979-10-04 | Traditional | PDF ↗ |
| K790545 | STRESS TESTING SYSTEM, LATERAL TILTING | Engineering Dynamics Corp. | 1979-06-06 | Traditional | PDF ↗ |
| K790544 | STRESS TESTING SYSTEM, MULTI-POSITION | Engineering Dynamics Corp. | 1979-06-05 | Traditional | PDF ↗ |
| K790552 | AS7 & AS8 MONITORS | Narco Air-Shields | 1979-05-01 | Traditional | PDF ↗ |
Product code DRT · Class II · Cardiovascular. Data: openFDA.