FDA 510(k) Applications for Medical Device Product Code "BZR"
(Mixer, Breathing Gases, Anesthesia Inhalation)

FDA 510(k) Number Applicant Device Name Decision Date
K103317 ATOM MEDICAL CORPORATION RESUSCITATION UNIT 105 04/20/2011
K925982 BIOMEDICAL DEVICES, INC. BMD AIR/OXYGEN BLENDER 10/07/1993
K895695 BIRD PRODUCTS CORP. BIRD MICROBLENDER M.R.I. 07/06/1990
K911962 BIRD PRODUCTS CORP. BIRD SENTRY AIR/OXYGEN MICROBLENDER 10/08/1991
K973646 BIRD PRODUCTS CORP. BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER 05/07/1998
K900722 BIRD PRODUCTS CORP. LOW FLOW N2O/02O MICROBLENDER 07/18/1990
K883038 BIRD PRODUCTS CORP. P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER 11/16/1988
K943797 BPR MEDICAL, LTD. BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER 05/11/1995
K092484 CARDINAL HEALTH 207, INC. HELIOX LOW FLOW SENTRY BLENDER 04/02/2010
K050381 CS MEDICAL INC. CS MEDICAL TTCF GAS DELIVERY SYSTEM 07/13/2005
K800764 DRAEGER MEDICAL, INC. DRAGER ORMC 04/29/1980
K953711 FISHER & PAYKEL ELECTRONICS LTD. AIR ENTRAINER 900RT008 11/08/1995
K760766 FRASER SWEATMAN, INC. PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXER 10/08/1976
K990293 HAMILTON MEDICAL, INC. ALADDIN II MONITORING OXYGEN/AIR MONITOR 03/16/1999
K960359 HAMILTON MEDICAL, INC. ALADDIN MONITORING OXYGEN/AIR MIXER 04/24/1996
K952878 INFRASONICS CORP. OXY/STAR LOW FLOW BLENDER 09/25/1995
K932557 LIFE SHIELD HEALTHCARE PRODUCTS, INC. HYPERINFLATION SYSTEM 07/22/1993
K101286 LINDE HEALTHCARE AB SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 10/20/2011
K001609 MALLARD MEDICAL, INC. MALLARD AIR OXYGEN ACCUBLENDER 08/10/2000
K883833 MATRIX MEDICA, INC. NITRONOX(R), FIRST RESPONSE NITRONOX(TM) 02/17/1989
K113232 MAXTEC, INC. MAXMIXING BLOCK 03/01/2012
K760017 MCKESSON CORP. CONSIOUS SEDATION (ANALOR P-76) 07/20/1976
K925591 MERIT MEDICAL SYSTEMS, INC. MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST 09/16/1993
K860373 NEWPORT MEDICAL INSTRUMENTS, INC. THE M100 AIR/OXYGEN MIXER 05/21/1986
K113687 O-TWO MEDICAL TECHNOLOGIES, INC. EQUINOX RELIEVE 04/30/2012
K853905 OHMEDA MEDICAL OHMEDA OXYGEN BLENDER 10/16/1985
K854769 P.A. MCCAULEY, INC. LNI MGV MEDICAL GAS MIXER 06/05/1986
K051192 PRAXAIR, INC. PRAXAIR MEDICAL AIR MIXER 09/06/2005
K932709 PRECISION MED PRODUCTS, LTD. PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM 07/23/1993
K090781 PRECISION MEDICAL, INC. HELIO2 BLENDER 08/13/2009
K053232 PRECISION MEDICAL, INC. PRECISION BLENDER 01/10/2006
K952021 PRIMA, INC. PRIMA HYUPERINFLATION SYSTEM 05/22/1995
K992503 SECHRIST INDUSTRIES, INC. SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES 08/10/1999
K802226 SECHRIST INDUSTRIES, INC. SECHRIST SERIES 3500 AIR-OXYGEN MIXER 09/26/1980
K841789 SHILEY, INC. SECHRIST AIR-OXYGEN MIXER & ANCILLARY 07/26/1984
K872278 SIEMENS ELEMA AB SIEMENS O2-AIR MIXER 965 09/03/1987
K800905 SIEMENS ELEMA AB SIEMENS-ELEMA AB O2-AIR MIXER 960 05/08/1980
K974372 SK MED AIR OXYGE MIXER 02/05/1998
K022864 SK MED SK MED M201 MIXER 04/11/2003
K031707 SK MED SK MED M201 PLUS MIXER 08/01/2003
K031860 SK MED SK MED ME202 MONITORING MIXER 01/21/2004
K081335 TENACORE HOLDINGS, INC. TENACORE OXYGEN BLENDER, MODEL TB-2000 11/14/2008
K800866 TRIDENT DENTAL, INC. ROYAL 05/28/1980
K800865 TRIDENT DENTAL, INC. WINDSOR 05/23/1980
K811393 VITAL SIGNS, INC. DOWNS CAP FLOW GENERATOR 06/09/1981


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact