BYL — Tent, Oxygen Class I
FDA product code BYL covers "Tent, Oxygen", a Class I medical device regulated under 21 CFR 868.5700. Submissions are reviewed by the Anesthesiology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BYL
- Device Class
- Class I
- Regulation Number
- 868.5700
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K935126 | nascor pty. | NASCOR IGLOO | October 18, 1994 |
| K905627 | nascor pty. | NASCOR OXYDOME | June 3, 1991 |
| K896608 | viratek | SPAG PAK | April 9, 1990 |
| K895866 | bird products | DIRD INGANT O2 (BIO 2 HOOD) | October 27, 1989 |
| K893714 | keystone veterinary supplies | KEYSTONE OXYGEN TENT | August 21, 1989 |
| K893713 | nova health systems | NOVA OXYGEN TENT | August 21, 1989 |
| K882396 | viratek | AEROSOL DELIVERY HOOD | August 1, 1988 |
| K851666 | medicomp | MEDI-COMP NEONATAL OXYGEN HOOD | August 6, 1985 |
| K852345 | safety sea systems | SEA-LONG NECKSEAL & HOOD | June 20, 1985 |
| K820640 | dhd medical products div. diemolding | HOO2D SEAT-INFANT | March 26, 1982 |
| K802653 | ann arbor plastics | MEDIUM SIZE OXYGEN HOOD #1547 | November 24, 1980 |