Oxygen Mask, Adult Vinyl
FDA 510(k) K790166 · Airlife, Inc.
510(k) numberK790166
Submission
- Device name
- Oxygen Mask, Adult Vinyl
- Applicant
- Airlife, Inc.
Mchenry, IL, US - Received
- January 12, 1979
- Decision date
- March 16, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYG – Mask, Oxygen
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5580
- Specialty
- Anesthesiology
Other 510(k)s with product code BYG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963298 | First Aid Kit(S)BYG · Traditional | Vector, Inc. | 11/06/1996SE |
| K962848 | Hans Rudolph Nasal CPAP MaskBYG · Traditional | Hans Rudolph, Inc. | 10/16/1996SE |
| K945482 | Disposable, CPAP Oxygen MaskBYG · Traditional | Fvtnks | 09/19/1995SE |
| K953464 | Westmed Pediatric & Adult Medium Concentration Oxygen MaskBYG · Traditional | Westmed, Inc. | 09/18/1995SE |
| K953039 | Various Adult & Child High Con/Nonrebreath Oxy MasksBYG · Traditional | Dadsun Corp., Ltd. | 09/15/1995SE |
| K945472 | Westmed Pediatric and Adult Aerosol MaskBYG · Traditional | Westmed Intl. | 02/07/1995SE |
| K942907 | Jemsdal MaskBYG · Traditional | Respan Products, Inc. | 08/31/1994SE |
| K940888 | System 22 Paediatric MaskBYG · Traditional | Medic-Aid , Ltd. | 04/19/1994SE |
| K940887 | System 22 Adult MaskBYG · Traditional | Medic-Aid , Ltd. | 04/19/1994SE |
| K931952 | Medway Oxygen MaskBYG · Traditional | Medway | 08/20/1993SE |
More from Medway
| 510(k) | Device | Decision |
|---|---|---|
| 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, Adult Vinyl cleared by the FDA?
Oxygen Mask, Adult Vinyl (K790166) received a 510(k) decision of Substantially Equivalent on March 16, 1979, 63 days after the submission was received.
What is the product code of K790166?
The FDA product code is BYG – Mask, Oxygen, a Class I (low risk) device regulated under 21 CFR 868.5580.