System 22 Adult Mask
FDA 510(k) K940887 · Medic-Aid , Ltd.
510(k) numberK940887
Submission
- Device name
- System 22 Adult Mask
- Applicant
- Medic-Aid , Ltd.
Sussex, U.K. Po21 3pp, GB - Received
- February 25, 1994
- Decision date
- April 19, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K931952 | Medway Oxygen MaskBYG · Traditional | Medway | 08/20/1993SE |
| K924069 | Surgico Oxygen MaskBYG · Traditional | Gujarat Surgico, Ltd. | 02/04/1993SE |
More from Gujarat Surgico, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K991685 | Halolite Aad System with Dedicated CompressorCAF · Traditional | 08/13/1999SE |
| K981772 | Halolite Aad SystemCAF · Traditional | 11/03/1998SE |
| K971933 | Port-NebCAF · Traditional | 08/01/1997SE |
| K934749 | Freeway Lite Nebulizer CompressorCAF · Traditional | 07/25/1994SE |
| K940888 | System 22 Paediatric MaskBYG · Traditional | 04/19/1994SE |
| K933535 | Ventstream Drug NebulizerCAF · Traditional | 01/24/1994SE |
| K924123 | Sidestream DisposableCAF · Traditional | 11/16/1992SE |
| K914152 | Sidestream Drug NebulizerCAF · Traditional | 05/05/1992SE |
Questions and answers
When was System 22 Adult Mask cleared by the FDA?
System 22 Adult Mask (K940887) received a 510(k) decision of Substantially Equivalent on April 19, 1994, 53 days after the submission was received.
What is the product code of K940887?
The FDA product code is BYG – Mask, Oxygen, a Class I (low risk) device regulated under 21 CFR 868.5580.