BYG · Mask, Oxygen
Anesthesiology · 21 CFR 868.5580 · Class 1
Overview
| Product Code | BYG |
|---|---|
| Device Name | Mask, Oxygen |
| Regulation | 21 CFR 868.5580 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (20 of 55)
Showing 20 most recent of 55 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K963298 | FIRST AID KIT(S) | Vector, Inc. | Nov 6, 1996 | SESE |
| K962848 | HANS RUDOLPH NASAL CPAP MASK | Hans Rudolph, Inc. | Oct 16, 1996 | SESE |
| K945482 | DISPOSABLE, CPAP OXYGEN MASK | Fvtnks | Sep 19, 1995 | SESE |
| K953464 | WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK | Westmed, Inc. | Sep 18, 1995 | SESE |
| K953039 | VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS | Dadsun Corp., Ltd. | Sep 15, 1995 | SESE |
| K945472 | WESTMED PEDIATRIC AND ADULT AEROSOL MASK | Westmed Intl. | Feb 7, 1995 | SESE |
| K942907 | JEMSDAL MASK | Respan Products, Inc. | Aug 31, 1994 | SESE |
| K940888 | SYSTEM 22 PAEDIATRIC MASK | Medic-Aid , Ltd. | Apr 19, 1994 | SESE |
| K940887 | SYSTEM 22 ADULT MASK | Medic-Aid , Ltd. | Apr 19, 1994 | SESE |
| K931952 | MEDWAY OXYGEN MASK | Medway | Aug 20, 1993 | SESE |
| K924069 | SURGICO OXYGEN MASK | Gujarat Surgico, Ltd. | Feb 4, 1993 | SESE |
| K921499 | SEAL RING FOR NASAL CPAP | Devilbiss Health Care, Inc. | Sep 17, 1992 | SESE |
| K913501 | TRACHEOSTOMY MASK | B & F Medical Products, Inc. | Jan 13, 1992 | SESE |
| K913383 | OXYGEN MASKS 81420, 81421, 81471 & 81461 | Specialty Packaging Producs, Inc. | Oct 18, 1991 | SESE |
| K913275 | VENTURI OXYGEN MASK | Specialty Packaging Producs, Inc. | Oct 10, 1991 | SESE |
| K913455 | OXYGEN MASKS 82400 & 82405 | Specialty Packaging Producs, Inc. | Oct 2, 1991 | SESE |
| K912633 | SALTER LABS INFANT MEDIUM CONCENTRATION MASK | Salter Labs | Jul 19, 1991 | SESE |
| K905288 | ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES | Med-Tek Innovations, Inc. | Apr 9, 1991 | SESE |
| K904719 | DISPOSABLE FACE MASK | Tri/Bor Medical, Inc. | Jan 2, 1991 | SESE |
| K904195 | DISPOSABLE FACE MASK | Bp , Ltd. | Sep 25, 1990 | SESE |
Top Applicants
- Airlife, Inc. — 6 clearances
- Ashai Co. , Ltd. — 4 clearances
- B & F Medical Products, Inc. — 3 clearances
- Dhd Medical Products Div. Diemolding Corp. — 3 clearances
- Specialty Packaging Producs, Inc. — 3 clearances
