BYDClass I
Condenser, Heat And Moisture (Artificial Nose)
21 CFR 868.5375 / Anesthesiology
BYD is the FDA product code for Condenser, Heat And Moisture (Artificial Nose), a class I device type, regulated under 21 CFR 868.5375. As of , FDA records hold 73 510(k) clearances under this code, the most recent dated , and 15 recalls.
Classification record
- Product code
- BYD
- Device name
- Condenser, Heat And Moisture (Artificial Nose)
- Regulation
- 21 CFR 868.5375
- Device class
- Class I
- Review panel
- Anesthesiology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 73
- Ingested recalls
- 15
Clearances, product code BYD
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1982 | 1 |
| 1984 | 4 |
| 1985 | 2 |
| 1986 | 1 |
| 1987 | 5 |
| 1988 | 5 |
| 1989 | 2 |
| 1990 | 8 |
| 1991 | 6 |
| 1992 | 2 |
| 1993 | 7 |
| 1994 | 10 |
| 1995 | 18 |
| 1996 | 1 |
Applicants with the most clearances
Product code BYD| Applicant | Clearances |
|---|---|
| Icor AB | 9 |
| Gibeck, Inc. | 7 |
| Gibeck Respiration | 6 |
| Artema Medical AB | 5 |
| Mallinckrodt Medical | 5 |
| Flocare Medical | 4 |
| Intertech Resources, Inc. | 4 |
| Pharma Systems AB | 3 |
| Vital Signs, Inc. | 3 |
| Hospitak, Inc. | 2 |
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.
