Combo Mask
FDA 510(k) K941336 · Gam Industries, Inc.
510(k) numberK941336
Submission
- Device name
- Combo Mask
- Applicant
- Gam Industries, Inc.
Petersburg, VA, US - Received
- March 21, 1994
- Decision date
- September 9, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KGB – Mask, Oxygen, Non-Rebreathing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5570
- Specialty
- Anesthesiology
Other 510(k)s with product code KGB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970688 | Pocket RescueKGB · Traditional | Cheen Houng Ent. Co. , Ltd. | 09/26/1997SE |
| K960401 | Ultimate SealKGB · Traditional | Hans Rudolph, Inc. | 06/20/1996SE |
| K935917 | Challenge Powder-Free, Hypoallergenic, Synthetic Surgical GlovesKGB · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/04/1994SE |
| K932347 | Compact MaskKGB · Traditional | Vital Signs, Inc. | 01/10/1994SE |
| K933583 | Nonrebreathing ValveKGB · Traditional | Hans Rudolph, Inc. | 01/03/1994SE |
| K933048 | Laerdal(Tm) Pocket Mask, ModificationKGB · Traditional | Laerdal Medical Corp. | 12/02/1993SE |
| K930336 | Profast(R)-Denture Adhesive CreamKGB · Traditional | Fittydent-Altwirth & Schmitt GmbH | 08/24/1993SE |
| K913164 | Non Rebreathing MaskKGB · Traditional | Specialty Packaging Producs, Inc. | 01/15/1992SE |
| K883766 | Mouth-To-Mask Ventilatory AdjunctKGB · Traditional | Medic One | 10/21/1988SE |
| K790162 | Oxygen Mask, Concentration Aerosol MaskKGB · Traditional | Airlife, Inc. | 04/20/1979SE |
More from Airlife, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K941641 | Disposable Emergency Obstetrical KitKNA · Traditional | 10/03/1994SE |
| K942021 | Mouth to Mouth BreatherCBP · Traditional | 06/22/1994SE |
| K936050 | Jaw SpreaderKBW · Traditional | 03/24/1994SE |
| K930401 | Aluminum FoilMGP · Traditional | 05/12/1993SE |
| K926290 | Burn SheetFPY · Traditional | 04/20/1993SE |
| K925590 | Multi-Trauma DressingNAB · Traditional | 04/08/1993SE |
| K915569 | Umbilical ClampHFW · Traditional | 09/23/1992SE |
| K915303 | Foil Baby BuntingKME · Traditional | 02/20/1992SE |
Questions and answers
When was Combo Mask cleared by the FDA?
Combo Mask (K941336) received a 510(k) decision of Substantially Equivalent on September 9, 1994, 172 days after the submission was received.
What is the product code of K941336?
The FDA product code is KGB – Mask, Oxygen, Non-Rebreathing, a Class I (low risk) device regulated under 21 CFR 868.5570.