FDA 510(k) Applications for Medical Device Product Code "CAD"
(Vaporizer, Anesthesia, Non-Heated)

FDA 510(k) Number Applicant Device Name Decision Date
K771150 AIR PRODUCTS & CHEMICALS, INC. COPPER KETTLE VAPORIZER PLUS 08/04/1977
K882500 ANESTHETIC VAPORIZER SERVICES VAPORIZER, ANESTHESIA, NON-HEATED 08/01/1988
K864605 BEAR MEDICAL SYSTEMS, INC. VAPLOK 02/03/1987
K942799 BLEASE USA, INC. DATUM 04/13/1995
K952083 CLOVER MEDICAL EQUIPMENT SERVICES, INC. TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE 10/21/1996
K761160 CYPRANE NORTH AMERICA, INC. MODEL CNA-1 VAPORIZER 12/09/1976
K990132 DATEX-OHMEDA, INC. DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC 01/21/1999
K002878 DATEX-OHMEDA, INC. DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER 09/21/2000
K000275 DATEX-OHMEDA, INC. DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA 04/12/2000
K012924 DATEX-OHMEDA, INC. DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER 01/30/2002
K031027 DATEX-OHMEDA, INC. DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) 06/26/2003
K172702 Datex-Ohmeda, Inc. Tec 820, Tec 850 01/04/2018
K884686 DENTSPLY INTL. VAPAMASTA 5 03/15/1989
K042276 DRAEGER MEDICAL, INC. D-VAPOR 09/23/2004
K821650 DRAEGER MEDICAL, INC. DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS 06/29/1982
K973051 DRAEGER MEDICAL, INC. DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS 10/30/1997
K981472 DRAEGER MEDICAL, INC. DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS 05/07/1998
K981773 DRAEGER MEDICAL, INC. DRAGER-VAPOR 19.3 07/06/1998
K971923 DRAEGER MEDICAL, INC. DRAGER-VAPOR 2000 09/16/1997
K771899 DRAEGER MEDICAL, INC. VAPOR 19 10/18/1977
K831427 FRASER HARLAKE, INC. CYPRANE TEC 4 CONTINUOUS FLOW VAPOR. 07/07/1983
K051666 GENERAL ANAESTHETIC SERVICES LIMITED GAV - GENERAL ANAESTHETIC VAPORIZER 08/23/2005
K872053 MAYFIELD INSTRUMENTS, LTD. "KEYFILL" 07/01/1987
K980489 MEDICAL INDUSTRIAL EQUIPMENT VAPAMASTA 6 08/31/1998
K760668 MEDISHIELD, INC. SELECTATEC SYSTEM 09/27/1976
K942055 NORTH AMERICAN GRAGER DRAGER-VAPOR 19.1 01/27/1995
K810289 OHIO MEDICAL PRODUCTS MODULUS VERNI-TROL ANESTHETIC VAPORIZER 03/04/1981
K821966 OHIO MEDICAL PRODUCTS MODULUS VERNI-TROL ANESTHETIC VAPORIZER 07/16/1982
K892057 OHMEDA MEDICAL OHMEDA TEC 5 CONTINUOUS FLOW VAPORIZER 04/26/1989
K942091 OHMEDA MEDICAL OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE 03/30/1995
K913593 OHMEDA MEDICAL OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER 10/06/1992
K053564 PENLON LIMITED KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 03/03/2006
K060331 PENLON LIMITED SIGMA ALPHA VAPORIZER 05/10/2006
K041076 PENLON LTD. DELTA T 08/09/2004
K960944 PENLON LTD. PPV VAPORIZER (MODIFICATION) 04/02/1996
K961468 PENLON LTD. QUIK-FIL VAPORIZER KEYED FILLER 07/16/1996
K002343 PENLON LTD. SIGMA DELTA 06/08/2001
K942545 PENLON LTD. SIGMA ELITE 02/03/1995
K844007 PENLON, INC. PENLON PPV VAPORIZER 03/12/1985
K936046 PENLON, INC. SIGMA ELITE 11/04/1994
K110608 PIRAMAL CRITCAL CARE, INC (FORMERLY MINRAD, INC) SEVOFLURANE VAPORIZER ADAPTOR 07/20/2011
K770021 PRECEPT, INC. MASK, FACE, SURGICAL 01/17/1977
K771892 PROMED CORP. VALVE ANESTHETIC 02/02/1978
K854202 RUSZ INSTRUMENTS, INC. ANESTHESIA VENTILATOR MODEL 100 04/11/1986
K150167 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD V60 Anesthetic Vaporizer 06/30/2015
K790359 SIEMENS CORP. HALOTHANE VAPORIZER 950, & ENFLURANE 951 03/21/1979
K841157 SIEMENS ELEMA AB HALOTHANE VAPORIZER 950, ENFLURANE 06/07/1984
K980884 SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS SEVOFLURANE VAPORIZER SV 953 08/19/1998
K843993 SOUTHMEDIC, INC. ANAESLOCK THREE VAPORIZER INTERLOCK HVA003 11/15/1984
K923265 SOUTHMEDIC, INC. FUNNEL ADAPTOR 03/18/1993
K945993 SOUTHMEDIC, INC. VAPOFIL 02/22/1995
K861839 SOUTHMEDIC, INC. VAPOFIL 05/21/1986
K860545 SOUTHMEDIC, INC. VAPORIZER SPACER 04/17/1986
K954801 TECHNIMECA MEDIC, INC. TECHFIL 01/25/1996
K953748 TECHNIMECA MEDIC, INC. TECHNOFIL 01/25/1996
K884090 VAPORFLOW TECHNOLOGY, INC. LUNDY VAPORIZER SYSTEM 01/24/1989


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