DQCClass I
Phonocardiograph
21 CFR 870.2390 / Cardiovascular
DQC is the FDA product code for Phonocardiograph, a class I device type, regulated under 21 CFR 870.2390. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- DQC
- Device name
- Phonocardiograph
- Regulation
- 21 CFR 870.2390
- Device class
- Class I
- Review panel
- Cardiovascular
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 18
- Ingested recalls
- 0
Clearances, product code DQC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 1 |
| 1978 | 1 |
| 1980 | 2 |
| 1981 | 1 |
| 1984 | 1 |
| 1986 | 1 |
| 1987 | 3 |
| 1990 | 2 |
| 1991 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 1 |
Applicants with the most clearances
Product code DQC| Applicant | Clearances |
|---|---|
| Intl. Acoustics, Inc. | 3 |
| Honeywell, Inc. | 2 |
| Life Sciences Manufacturing, Inc. | 2 |
| Acuson Corp. | 1 |
| Andries Tek, Inc. | 1 |
| Burdick Corp. | 1 |
| Cardiophonics, Inc. | 1 |
| Echo Ultrasound | 1 |
| Edwards Laboratories | 1 |
| Flowscan, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
