Product code DRQ
- Device name
- Amplifier And Signal Conditioner, Transducer Signal
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2060
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172216 | ACIST RXi Mini System | Acist Medical Systems, Inc. | 2017-08-18 |
| 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 |
| 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 |
| K050006 | BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO | C.R. Bard, Inc. | 2005-05-27 |
| K050974 | DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS | Draeger Medical Systems, Inc. | 2005-04-29 |
| K033807 | INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER | Draeger Medical Systems, Inc. | 2004-03-09 |
| K013205 | MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 | Millar Instruments, Inc. | 2002-07-02 |
| K020277 | SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER | Siemens Medical Solutions USA, Inc. | 2002-02-19 |
| K010640 | SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER | Siemens Medical Solutions USA, Inc. | 2001-03-20 |
| K913875 | BARD(R) BIOPOTENTIAL AMPLIFIER II | Bard Electrophysiology | 1991-11-27 |
| K913110 | PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED | Microwave Medical Systems, Inc. | 1991-10-10 |
| K910905 | SFA-II MICROPROCESSOR-CONTROLLED MODULE | Life Sciences Manufacturing, Inc. | 1991-07-24 |
| K904749 | TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 | Transtracheal Systems | 1991-03-01 |
| K901358 | BARD BIOPOTENTIAL AMPLIFIER II | C.R. Bard, Inc. | 1990-05-09 |
| K894295 | ASTRO-MED ASC-951 PRESSURE PROCESSOR | Astro-Med, Inc. | 1990-01-18 |
| K885252 | MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001 | Ep Technologies, Inc. | 1989-01-13 |
| K870783 | BPA CARDIOVASCULAR PRESSURE AMPLIFIER | Fisher Imaging Corp. | 1987-04-27 |
| K870728 | TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701 | A&D Engineering, Inc. | 1987-03-27 |
| K864320 | SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE | Cordis Corp. | 1987-02-20 |
| K830914 | EXTERNAL VALVE FUNCTION BLOCK | Honeywell, Inc. | 1983-08-12 |
| K802961 | TRANSDUCER DOME, CAT.#SD-101 | Sorensen Research | 1980-12-31 |
| K803011 | DISPOSABLE DIAPHRAGM DONE | Sorensen Research | 1980-12-31 |
| K800488 | SURGERY DISPLAY SYSTEM | Kent Barker & Assoc. | 1980-04-16 |
| K792190 | MODEL CF-300 THREE CHANNEL FLOW METER | Wilton Webster Laboratories | 1979-11-21 |
| K780571 | BLOOD PRESSURE MODULE | C-V Monitors Corp. | 1978-05-09 |
| K770247 | D.C. AMPLIFIER MODULE | Mennen Greatbatch Electonics | 1977-02-14 |
| K761017 | PRESSURE MODULE (MODEL P3) | Datascope Corp. | 1976-11-15 |
Related GUDID Devices#
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|---|---|---|---|
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| 04931921017159 | CNS-2101 Central Monitor | NIHON KOHDEN CORPORATION | 2023-10-30 |
| 04931921017166 | CNS-2101 Central Monitor | NIHON KOHDEN CORPORATION | 2023-10-01 |
| 00868924000267 | Monitor Input Cable, Mikro-Cath to EP-Tracer System | MILLAR INC. | 2021-07-16 |
| 00884838093225 | Avalon Toco+ Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093218 | Avalon Toco MP Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093188 | Avalon Toco+ MP Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093195 | Avalon Ultrasound Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093201 | Avalon ECG/IUP Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 08714729883241 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | 2019-12-13 |
| 08714729885900 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | 2019-12-13 |
| 08714729883289 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | 2019-12-13 |
| 08714729883296 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | 2019-12-13 |
| 08714729883333 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | 2019-12-13 |
| 08714729883340 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | 2019-12-13 |
| 08714729885825 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | 2019-12-13 |
| 08714729885832 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | 2019-12-13 |
| 08714729885863 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | 2019-12-13 |
| 08714729885870 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | 2019-12-13 |
| 08714729883234 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | 2019-12-13 |
| 08714729882992 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | 2019-12-13 |
| 08714729882985 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | 2019-12-13 |
| 00884838020849 | SO2 Optical Module | Philips Medizin Systeme Böblingen GmbH | 2018-12-18 |
| 10841716101790 | ACIST RXi® Mini Navvus Interface | ACIST MEDICAL SYSTEMS, INC. | 2017-09-27 |
| 10841716101783 | ACIST RXi® Mini Processing Unit | ACIST MEDICAL SYSTEMS, INC. | 2017-09-27 |
| 10841716101769 | ACIST RXi® Mini Mount | ACIST MEDICAL SYSTEMS, INC. | 2017-09-27 |
| 20884838072248 | Spirometry Sensor | Philips Medizin Systeme Böblingen GmbH | 2017-01-20 |
| 08714729905738 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729905721 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 00840682104081 | NA | GE Healthcare Finland Oy | 2016-06-03 |