BYG · Class I · 21 CFR 868.5580

FDA Product Code BYG: Mask, Oxygen

Leading manufacturers include Airlife, Inc., Dhd Medical Products Div. Diemolding Corp. and Salter Labs.

55
Total
55
Cleared
67d
Avg days
1976
Since

FDA 510(k) Cleared Mask, Oxygen Devices (Product Code BYG)

55 devices
1–24 of 55
Cleared Sep 17, 1992
SEAL RING FOR NASAL CPAP
K921499
Devilbiss Health Care, Inc.
Anesthesiology · 170d
Cleared Jul 19, 1991
SALTER LABS INFANT MEDIUM CONCENTRATION MASK
K912633
Salter Labs
Anesthesiology · 35d
Cleared Aug 15, 1989
KENDALL CURITY OXYGEN MASK
K892434
The Kendal Co.
Anesthesiology · 127d
Cleared Mar 14, 1989
SINGLE PATIENT USE NASAL (CPAP) CIRCUIT
K890193
Puritan Bennett Corp.
Anesthesiology · 55d
Cleared Feb 10, 1987
SALTER LABS #4004/4104 OXYGEN MASK W/C02 SAMP LINE
K865047
Salter Labs
Anesthesiology · 48d
Cleared Mar 19, 1986
MEDIUM CONCENTRATION OXYGEN MASKS
K860869
Dhd Medical Products Div. Diemolding Corp.
Anesthesiology · 22d
Cleared Mar 19, 1986
AEROSOL MASKS/ADULT & PAEDIATRIC
K860870
Dhd Medical Products Div. Diemolding Corp.
Anesthesiology · 22d
Cleared Mar 19, 1986
TRACHEOSTOMY MASKS/ADULT & PAEDIATRIC
K860871
Dhd Medical Products Div. Diemolding Corp.
Anesthesiology · 22d
Cleared Jul 01, 1981
PEDIATRIC OXYGEN MASKS
K811711
Airlife, Inc.
Anesthesiology · 14d
Cleared Oct 03, 1980
PEDIATRIC OXYGEN OR AEROSOL MASKS,
K802323
Airlife, Inc.
Anesthesiology · 10d
Cleared Sep 09, 1980
PEEP FACE MASK
K801883
Vital Signs, Inc.
Anesthesiology · 33d
Cleared Mar 16, 1979
OXYGEN MASK, ADULT VINYL
K790166
Airlife, Inc.
Anesthesiology · 63d
Cleared Feb 16, 1979
AEROSOL MASK
K790163
Airlife, Inc.
Anesthesiology · 35d
Cleared Feb 06, 1979
OXYGEN MASK REBREATHER
K790164
Airlife, Inc.
Anesthesiology · 25d
Cleared Feb 06, 1979
OXYGEN MASK-HIGH CONCENTRATION
K790165
Airlife, Inc.
Anesthesiology · 25d
Cleared Jun 27, 1977
AEROSOL MASK
K770995
Ohio Medical Products
Anesthesiology · 26d

About Product Code BYG - Regulatory Context