DSFClass I
Recorder, Paper Chart
21 CFR 870.2810 / Cardiovascular
DSF is the FDA product code for Recorder, Paper Chart, a class I device type, regulated under 21 CFR 870.2810. As of , FDA records hold 87 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- DSF
- Device name
- Recorder, Paper Chart
- Regulation
- 21 CFR 870.2810
- 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
- 87
- Ingested recalls
- 1
Clearances, product code DSF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 4 |
| 1977 | 6 |
| 1978 | 7 |
| 1979 | 5 |
| 1980 | 4 |
| 1981 | 8 |
| 1982 | 7 |
| 1983 | 5 |
| 1984 | 4 |
| 1985 | 7 |
| 1986 | 4 |
| 1987 | 4 |
| 1988 | 5 |
| 1989 | 9 |
| 1990 | 5 |
| 1991 | 3 |
Applicants with the most clearances
Product code DSF| Applicant | Clearances |
|---|---|
| Honeywell, Inc. | 6 |
| Hewlett-Packard Co. | 5 |
| Edentec Corp. | 4 |
| Eaton Medical Group | 3 |
| GE Medical Systems Information Technologies, Inc. | 3 |
| Litton Medical Electronics | 3 |
| Physio Control, Inc. | 3 |
| Air-Shields, Inc. | 2 |
| American Edwards Laboratories | 2 |
| Astro-Med, Inc. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this code- A-M Systems
- AB Medica Group S. A.
- Advanced Instrumentations, Inc.
- AirLife Finland Oy
- Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.
- Amphenol Medical Technologies (Dongguan) Co., Ltd.
- ApS Trading Ood
- Becton Dickinson & Co
- Blumberg GmbH & Co. KG
- CBR Enterprise Limited
- Ceracarta SpA
- DHL Supply Chain (Netherlands) B.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.
