BZR · Class II · 21 CFR 868.5330

FDA Product Code BZR: Mixer, Breathing Gases, Anesthesia Inhalation

Leading manufacturers include Bird Products Corp., Maxtec, LLC and Baldus Sedation GmbH & Co. KG.

55
Total
55
Cleared
142d
Avg days
1976
Since
55 devices
25–48 of 55
Cleared May 22, 1995
PRIMA HYUPERINFLATION SYSTEM
K952021
Prima, Inc.
Anesthesiology · 24d
Cleared Sep 16, 1993
MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST
K925591
Merit Medical Systems, Inc.
Anesthesiology · 315d
Cleared Jul 23, 1993
PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM
K932709
Precision Med Products, Ltd.
Anesthesiology · 49d
Cleared Jul 22, 1993
HYPERINFLATION SYSTEM
K932557
Life Shield Healthcare Products, Inc.
Anesthesiology · 56d
Cleared Oct 08, 1991
BIRD SENTRY AIR/OXYGEN MICROBLENDER
K911962
Bird Products Corp.
Anesthesiology · 159d
Cleared Jul 18, 1990
LOW FLOW N2O/02O MICROBLENDER
K900722
Bird Products Corp.
Anesthesiology · 154d
Cleared Jul 06, 1990
BIRD MICROBLENDER M.R.I.
K895695
Bird Products Corp.
Anesthesiology · 288d
Cleared Nov 16, 1988
P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER
K883038
Bird Products Corp.
Anesthesiology · 120d
Cleared Sep 03, 1987
SIEMENS O2-AIR MIXER 965
K872278
Siemens Elema AB
Anesthesiology · 80d
Cleared May 21, 1986
THE M100 AIR/OXYGEN MIXER
K860373
Newport Medical Instruments, Inc.
Anesthesiology · 107d
Cleared Oct 16, 1985
OHMEDA OXYGEN BLENDER
K853905
Ohmeda Medical
Anesthesiology · 26d
Cleared Jul 26, 1984
SECHRIST AIR-OXYGEN MIXER & ANCILLARY
K841789
Shiley, Inc.
Anesthesiology · 87d
Cleared Jun 09, 1981
DOWNS CAP FLOW GENERATOR
K811393
Vital Signs, Inc.
Anesthesiology · 22d
Cleared Sep 26, 1980
SECHRIST SERIES 3500 AIR-OXYGEN MIXER
K802226
Sechrist Industries, Inc.
Anesthesiology · 14d
Cleared May 08, 1980
SIEMENS-ELEMA AB O2-AIR MIXER 960
K800905
Siemens Elema AB
Anesthesiology · 17d
Cleared Apr 29, 1980
DRAGER ORMC
K800764
Draeger Medical, Inc.
Anesthesiology · 22d