DRQ — Amplifier And Signal Conditioner, Transducer Signal Class II
FDA product code DRQ covers "Amplifier And Signal Conditioner, Transducer Signal", a Class II medical device regulated under 21 CFR 870.2060. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DRQ
- Device Class
- Class II
- Regulation Number
- 870.2060
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K172216 | acist medical systems | ACIST RXi Mini System | August 18, 2017 |
| K152693 | boston scientific corporation | CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIG | October 21, 2015 |
| K150235 | boston scientific corporation | CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARS | April 22, 2015 |
| K050006 | c.r. bard | BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CH | May 27, 2005 |
| K050974 | draeger medical systems | DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS | April 29, 2005 |
| K033807 | draeger medical systems | INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER | March 9, 2004 |
| K013205 | millar instruments | MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 | July 2, 2002 |
| K020277 | siemens medical solutions usa | SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER | February 19, 2002 |
| K010640 | siemens medical solutions usa | SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER | March 20, 2001 |
| K913875 | bard electrophysiology | BARD(R) BIOPOTENTIAL AMPLIFIER II | November 27, 1991 |
| K913110 | microwave medical systems | PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED | October 10, 1991 |
| K910905 | life sciences manufacturing | SFA-II MICROPROCESSOR-CONTROLLED MODULE | July 24, 1991 |
| K904749 | transtracheal systems | TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 | March 1, 1991 |
| K901358 | c.r. bard | BARD BIOPOTENTIAL AMPLIFIER II | May 9, 1990 |
| K894295 | astro-med | ASTRO-MED ASC-951 PRESSURE PROCESSOR | January 18, 1990 |
| K885252 | ep technologies | MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001 | January 13, 1989 |
| K870783 | fisher imaging | BPA CARDIOVASCULAR PRESSURE AMPLIFIER | April 27, 1987 |
| K870728 | a and d engineering | TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701 | March 27, 1987 |
| K864320 | cordis | SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE | February 20, 1987 |
| K830914 | honeywell | EXTERNAL VALVE FUNCTION BLOCK | August 12, 1983 |