FDA Product Code
FDA Product Code DRQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2060
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K172216 | ACIST RXi Mini System | Acist Medical Systems, Inc. | 2017-08-18 | Special | PDF ↗ |
| K152693 | CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels | Boston Scientific Corporation | 2015-10-21 | Special | PDF ↗ |
| K150235 | CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels | Boston Scientific Corporation | 2015-04-22 | Special | PDF ↗ |
| K050006 | BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO | C.R. Bard, Inc. | 2005-05-27 | Traditional | PDF ↗ |
| K050974 | DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS | Draeger Medical Systems, Inc. | 2005-04-29 | Special | PDF ↗ |
| K033807 | INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER | Draeger Medical Systems, Inc. | 2004-03-09 | Special | PDF ↗ |
| K013205 | MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 | Millar Instruments, Inc. | 2002-07-02 | Traditional | PDF ↗ |
| K020277 | SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER | Siemens Medical Solutions USA, Inc. | 2002-02-19 | Special | PDF ↗ |
| K010640 | SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER | Siemens Medical Solutions USA, Inc. | 2001-03-20 | Special | PDF ↗ |
| K913875 | BARD(R) BIOPOTENTIAL AMPLIFIER II | Bard Electrophysiology | 1991-11-27 | Traditional | PDF ↗ |
| K913110 | PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED | Microwave Medical Systems, Inc. | 1991-10-10 | Traditional | PDF ↗ |
| K910905 | SFA-II MICROPROCESSOR-CONTROLLED MODULE | Life Sciences Manufacturing, Inc. | 1991-07-24 | Traditional | PDF ↗ |
| K904749 | TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 | Transtracheal Systems | 1991-03-01 | Traditional | PDF ↗ |
| K901358 | BARD BIOPOTENTIAL AMPLIFIER II | C.R. Bard, Inc. | 1990-05-09 | Traditional | PDF ↗ |
| K894295 | ASTRO-MED ASC-951 PRESSURE PROCESSOR | Astro-Med, Inc. | 1990-01-18 | Traditional | PDF ↗ |
| K885252 | MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001 | Ep Technologies, Inc. | 1989-01-13 | Traditional | PDF ↗ |
| K870783 | BPA CARDIOVASCULAR PRESSURE AMPLIFIER | Fisher Imaging Corp. | 1987-04-27 | Traditional | PDF ↗ |
| K870728 | TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701 | A&D Engineering, Inc. | 1987-03-27 | Traditional | PDF ↗ |
| K864320 | SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE | Cordis Corp. | 1987-02-20 | Traditional | PDF ↗ |
| K830914 | EXTERNAL VALVE FUNCTION BLOCK | Honeywell, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K803011 | DISPOSABLE DIAPHRAGM DONE | Sorensen Research | 1980-12-31 | Traditional | PDF ↗ |
| K802961 | TRANSDUCER DOME, CAT.#SD-101 | Sorensen Research | 1980-12-31 | Traditional | PDF ↗ |
| K800488 | SURGERY DISPLAY SYSTEM | Kent Barker & Assoc. | 1980-04-16 | Traditional | PDF ↗ |
| K792190 | MODEL CF-300 THREE CHANNEL FLOW METER | Wilton Webster Laboratories | 1979-11-21 | Traditional | PDF ↗ |
| K780571 | BLOOD PRESSURE MODULE | C-V Monitors Corp. | 1978-05-09 | Traditional | PDF ↗ |
| K770247 | D.C. AMPLIFIER MODULE | Mennen Greatbatch Electonics | 1977-02-14 | Traditional | PDF ↗ |
| K761017 | PRESSURE MODULE (MODEL P3) | Datascope Corp. | 1976-11-15 | Traditional | PDF ↗ |
Product code DRQ · Class II · Cardiovascular. Data: openFDA.