DRQClass II
Amplifier And Signal Conditioner, Transducer Signal
21 CFR 870.2060 / Cardiovascular
DRQ is the FDA product code for Amplifier And Signal Conditioner, Transducer Signal, a class II device type, regulated under 21 CFR 870.2060. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- DRQ
- Device name
- Amplifier And Signal Conditioner, Transducer Signal
- Regulation
- 21 CFR 870.2060
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 27
- Ingested recalls
- 1
Clearances, product code DRQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 1 |
| 1978 | 1 |
| 1979 | 1 |
| 1980 | 3 |
| 1983 | 1 |
| 1987 | 3 |
| 1989 | 1 |
| 1990 | 2 |
| 1991 | 4 |
| 2001 | 1 |
| 2002 | 2 |
| 2004 | 1 |
| 2005 | 2 |
| 2015 | 2 |
| 2017 | 1 |
Applicants with the most clearances
Product code DRQ| Applicant | Clearances |
|---|---|
| Boston Scientific Corporation | 2 |
| C.R. Bard Inc | 2 |
| Draeger Medical Systems, Inc. | 2 |
| Siemens Medical Solutions USA, Inc. | 2 |
| Sorensen Research | 2 |
| A and D Engineering, Inc. | 1 |
| Acist Medical Systems, Inc. | 1 |
| Astro-Med, Inc. | 1 |
| Bard Electrophysiology | 1 |
| C-V Monitors Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Acist Medical Systems, Inc.
- Amphenol Alden Products Company
- Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.
- Amphenol Medical Technologies (Dongguan) Co., Ltd.
- Boston Scientific Corporation
- CD Leycom
- Creation Technologies
- Datascope Corp.
- DHL Supply Chain (Netherlands) B.V.
- Draeger Medical Systems, Inc.
- GE Healthcare Finland Oy
- GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
