DRQ · Amplifier And Signal Conditioner, Transducer Signal
Cardiovascular · 21 CFR 870.2060 · Class 2
Overview
| Product Code | DRQ |
|---|---|
| Device Name | Amplifier And Signal Conditioner, Transducer Signal |
| Regulation | 21 CFR 870.2060 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A transducer signal amplifier and conditioner is a device used to provide the excitation energy for the transducer and to amplify or condition the signal emitted by the transducer.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K172216 | ACIST RXi Mini System | Acist Medical Systems, Inc. | Aug 18, 2017 | SESE |
| K152693 | CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels | Boston Scientific Corporation | Oct 21, 2015 | SESE |
| K150235 | CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels | Boston Scientific Corporation | Apr 22, 2015 | SESE |
| K050006 | BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO | C.R. Bard, Inc. | May 27, 2005 | SESE |
| K050974 | DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS | Draeger Medical Systems, Inc. | Apr 29, 2005 | SESE |
| K033807 | INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER | Draeger Medical Systems, Inc. | Mar 9, 2004 | SESE |
| K013205 | MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 | Millar Instruments, Inc. | Jul 2, 2002 | SESE |
| K020277 | SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER | Siemens Medical Solutions USA, Inc. | Feb 19, 2002 | SESE |
| K010640 | SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER | Siemens Medical Solutions USA, Inc. | Mar 20, 2001 | SESE |
| K913875 | BARD(R) BIOPOTENTIAL AMPLIFIER II | Bard Electrophysiology | Nov 27, 1991 | SESE |
| K913110 | PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED | Microwave Medical Systems, Inc. | Oct 10, 1991 | SESE |
| K910905 | SFA-II MICROPROCESSOR-CONTROLLED MODULE | Life Sciences Manufacturing, Inc. | Jul 24, 1991 | SESE |
| K904749 | TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 | Transtracheal Systems | Mar 1, 1991 | SESE |
| K901358 | BARD BIOPOTENTIAL AMPLIFIER II | C.R. Bard, Inc. | May 9, 1990 | SESE |
| K894295 | ASTRO-MED ASC-951 PRESSURE PROCESSOR | Astro-Med, Inc. | Jan 18, 1990 | SESE |
| K885252 | MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001 | Ep Technologies, Inc. | Jan 13, 1989 | SESE |
| K870783 | BPA CARDIOVASCULAR PRESSURE AMPLIFIER | Fisher Imaging Corp. | Apr 27, 1987 | SESE |
| K870728 | TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701 | A&D Engineering, Inc. | Mar 27, 1987 | SESE |
| K864320 | SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE | Cordis Corp. | Feb 20, 1987 | SESE |
| K830914 | EXTERNAL VALVE FUNCTION BLOCK | Honeywell, Inc. | Aug 12, 1983 | SESE |
Top Applicants
- Boston Scientific Corporation — 2 clearances
- C.R. Bard, Inc. — 2 clearances
- Draeger Medical Systems, Inc. — 2 clearances
- Siemens Medical Solutions USA, Inc. — 2 clearances
- Sorensen Research — 2 clearances
