OXYGEN MASK-HIGH CONCENTRATION
FDA 510(k) clearance K790165 · decided 1979-02-06
Clearance details
- K-number
- K790165
- Device name
- OXYGEN MASK-HIGH CONCENTRATION
- Applicant
- Airlife, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-01-12
- Decision date
- 1979-02-06
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- BYG
- Device class
- 1
- Regulation number
- 868.5580
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Airlife
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FIRST AID KIT(S) (K963298) | Vector, Inc. | 1996-11-06 |
| HANS RUDOLPH NASAL CPAP MASK (K962848) | Hans Rudolph, Inc. | 1996-10-16 |
| DISPOSABLE, CPAP OXYGEN MASK (K945482) | Fvtnks | 1995-09-19 |
| WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK (K953464) | Westmed, Inc. | 1995-09-18 |
| VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS (K953039) | Dadsun Corp., Ltd. | 1995-09-15 |
| WESTMED PEDIATRIC AND ADULT AEROSOL MASK (K945472) | Westmed Intl. | 1995-02-07 |
| JEMSDAL MASK (K942907) | Respan Products, Inc. | 1994-08-31 |
| SYSTEM 22 ADULT MASK (K940887) | Medic-Aid , Ltd. | 1994-04-19 |
| SYSTEM 22 PAEDIATRIC MASK (K940888) | Medic-Aid , Ltd. | 1994-04-19 |
| MEDWAY OXYGEN MASK (K931952) | Medway | 1993-08-20 |
| SURGICO OXYGEN MASK (K924069) | Gujarat Surgico, Ltd. | 1993-02-04 |
| SEAL RING FOR NASAL CPAP (K921499) | Devilbiss Health Care, Inc. | 1992-09-17 |
Recalls involving this device
No recalls on record reference this clearance.