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 | Oct 18, 1994 |
| K905627 | Nascor Pty. | NASCOR OXYDOME | Jun 3, 1991 |
| K896608 | Viratek | SPAG PAK | Apr 9, 1990 |
| K895866 | Bird Products | DIRD INGANT O2 (BIO 2 HOOD) | Oct 27, 1989 |
| K893713 | Nova Health Systems | NOVA OXYGEN TENT | Aug 21, 1989 |
| K893714 | Keystone Veterinary Supplies | KEYSTONE OXYGEN TENT | Aug 21, 1989 |
| K882396 | Viratek | AEROSOL DELIVERY HOOD | Aug 1, 1988 |
| K851666 | Medicomp | MEDI-COMP NEONATAL OXYGEN HOOD | Aug 6, 1985 |
| K852345 | Safety Sea Systems | SEA-LONG NECKSEAL & HOOD | Jun 20, 1985 |
| K820640 | Dhd Medical Products Div. Diemolding | HOO2D SEAT-INFANT | Mar 26, 1982 |
| K802653 | Ann Arbor Plastics | MEDIUM SIZE OXYGEN HOOD #1547 | Nov 24, 1980 |