FOG — Hood, Oxygen, Infant Class I
FDA product code FOG covers "Hood, Oxygen, Infant", a Class I medical device regulated under 21 CFR 868.5700. Submissions are reviewed by the Anesthesiology panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FOG
- 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 |
|---|---|---|---|
| K973128 | Olympus America | OLYMPUS NA-10J-1 ASPIRATION NEEDLE | Nov 18, 1997 |
| K962182 | Promedic | BURLEW INFANT HOOD | Jul 15, 1996 |
| K955482 | Advantage Medical Services | SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION) | Jan 30, 1996 |
| K830781 | Jayco Pharmaceuticals | ENDO-GUARD | Mar 31, 1983 |
| K792144 | Utah Medical Products | DISPOSA-HOOD | Dec 5, 1979 |
| K791861 | Ann Arbor Plastics | OXYGEN HOODS | Oct 4, 1979 |
| K790860 | Plastics Supplies And Products | RT-HOOD | May 29, 1979 |
| K780220 | Shiley | HOOD, INFANT OXYGEN | Apr 10, 1978 |
| K770754 | American Cystocope Makers | DUODENOSCOPE, MOLEL TX-6 | Apr 28, 1977 |