KGB — Mask, Oxygen, Non-Rebreathing Class I
FDA product code KGB covers "Mask, Oxygen, Non-Rebreathing", a Class I medical device regulated under 21 CFR 868.5570. Submissions are reviewed by the Anesthesiology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KGB
- Device Class
- Class I
- Regulation Number
- 868.5570
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K970688 | cheen houng ent. co. | POCKET RESCUE | September 26, 1997 |
| K960401 | hans rudolph | ULTIMATE SEAL | June 20, 1996 |
| K941336 | gam industries | COMBO MASK | September 9, 1994 |
| K935917 | bd becton dickinson vacutainer systems preanalytic | CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES | February 4, 1994 |
| K932347 | vital signs | COMPACT MASK | January 10, 1994 |
| K933583 | hans rudolph | NONREBREATHING VALVE | January 3, 1994 |
| K933048 | laerdal medical | LAERDAL(TM) POCKET MASK, MODIFICATION | December 2, 1993 |
| K930336 | fittydent-altwirth and schmitt | PROFAST(R)-DENTURE ADHESIVE CREAM | August 24, 1993 |
| K913164 | specialty packaging producs | NON REBREATHING MASK | January 15, 1992 |
| K883766 | medic one | MOUTH-TO-MASK VENTILATORY ADJUNCT | October 21, 1988 |
| K790161 | airlife | OXYGEN MASK W/RESERVOIR BAG | April 20, 1979 |
| K790162 | airlife | OXYGEN MASK, CONCENTRATION AEROSOL MASK | April 20, 1979 |
| K781414 | vitalab products | MASK, OXYGEN, NONBREATHING | September 7, 1978 |