Panels › Anesthesiology › Product code KGB · Class 1
Mask, Oxygen, Non-Rebreathing
Regulation 868.5570
0510(k)s in 12 months (13 all time)
0recalls in 12 months (8 all time)
6recalls that name a 510(k)
Top companies in KGB
| Company | 510(k)s | Recalls |
|---|---|---|
| Westmed, Inc. | 0 | 6 |
| Airlife, Inc. | 2 | 0 |
| Hans Rudolph, Inc. | 2 | 0 |
| Medex Inc | 0 | 2 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Cheen Houng Ent. Co. , Ltd. | 1 | 0 |
| Fittydent-Altwirth & Schmitt GmbH | 1 | 0 |
| Gam Industries, Inc. | 1 | 0 |
| Laerdal Medical Corp. | 1 | 0 |
| Medic One | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 26, 1997 | K970688 | POCKET RESCUE Cheen Houng Ent. Co. , Ltd., TW | KGB |
| Jun 20, 1996 | K960401 | ULTIMATE SEAL Hans Rudolph, Inc. | KGB |
| Sep 9, 1994 | K941336 | COMBO MASK Gam Industries, Inc. | KGB |
| Feb 4, 1994 | K935917 | CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES Bd Becton Dickinson Vacutainer Systems Preanalytic | KGB |
| Jan 10, 1994 | K932347 | COMPACT MASK Vital Signs, Inc. | KGB |
| Jan 3, 1994 | K933583 | NONREBREATHING VALVE Hans Rudolph, Inc. | KGB |
| Dec 2, 1993 | K933048 | LAERDAL(TM) POCKET MASK, MODIFICATION Laerdal Medical Corp. | KGB |
| Aug 24, 1993 | K930336 | PROFAST(R)-DENTURE ADHESIVE CREAM Fittydent-Altwirth & Schmitt GmbH | KGB |
| Jan 15, 1992 | K913164 | NON REBREATHING MASK Specialty Packaging Producs, Inc. | KGB |
| Oct 21, 1988 | K883766 | MOUTH-TO-MASK VENTILATORY ADJUNCT Medic One | KGB |
| Apr 20, 1979 | K790162 | OXYGEN MASK, CONCENTRATION AEROSOL MASK Airlife, Inc. | KGB |
| Apr 20, 1979 | K790161 | OXYGEN MASK W/RESERVOIR BAG Airlife, Inc. | KGB |
| Sep 7, 1978 | K781414 | MASK, OXYGEN, NONBREATHING Vitalab Products Corp. | KGB |
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