Oxygen Mask W/Reservoir Bag
FDA 510(k) K790161 · Airlife, Inc.
510(k) numberK790161
Submission
- Device name
- Oxygen Mask W/Reservoir Bag
- Applicant
- Airlife, Inc.
Mchenry, IL, US - Received
- January 12, 1979
- Decision date
- April 20, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K941336 | Combo MaskKGB · Traditional | Gam Industries, Inc. | 09/09/1994SE |
| 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 |
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|---|---|---|
| K834573 | Aqua TrapBYH · Traditional | 03/05/1984SE |
| K834570 | Volume Ventilator Circuit W/Water TrapBZO · Traditional | 03/05/1984SE |
| K834077 | Single Use Nebulizer-Adjust-Air EntrainCAF · Traditional | 12/12/1983SE |
| K833196 | Volume Ventilator Circuit-NebulizerCAI · Traditional | 11/03/1983SE |
| K833197 | Trach Swive/ConnectorBTR · Traditional | 10/28/1983SE |
| K832725 | Dual Dial Venturi Style MaskBYF · Traditional | 09/20/1983SE |
| K831246 | Whistler In-Line Pressure Release ValveCBP · Traditional | 07/26/1983SE |
| K830895 | Single Use Nebulizer, Adjust. Air-CAF · Traditional | 04/28/1983SE |
| K830896 | Humidifier, with or Without AdapterKFZ · Traditional | 04/18/1983SE |
| K821129 | Airlife Nebulizer HeaterCAF · Traditional | 05/18/1982SE |
Questions and answers
When was Oxygen Mask W/Reservoir Bag cleared by the FDA?
Oxygen Mask W/Reservoir Bag (K790161) received a 510(k) decision of Substantially Equivalent on April 20, 1979, 98 days after the submission was received.
What is the product code of K790161?
The FDA product code is KGB – Mask, Oxygen, Non-Rebreathing, a Class I (low risk) device regulated under 21 CFR 868.5570.