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

FDA 510(k) Number Applicant Device Name Decision Date
K952083 CLOVER MEDICAL EQUIPMENT SERVICES, INC. TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE 10/21/1996
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
K042276 DRAEGER MEDICAL, INC. D-VAPOR 09/23/2004
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
K051666 GENERAL ANAESTHETIC SERVICES LIMITED GAV - GENERAL ANAESTHETIC VAPORIZER 08/23/2005
K980489 MEDICAL INDUSTRIAL EQUIPMENT VAPAMASTA 6 08/31/1998
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
K110608 PIRAMAL CRITCAL CARE, INC (FORMERLY MINRAD, INC) SEVOFLURANE VAPORIZER ADAPTOR 07/20/2011
K150167 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD V60 Anesthetic Vaporizer 06/30/2015
K980884 SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS SEVOFLURANE VAPORIZER SV 953 08/19/1998
K954801 TECHNIMECA MEDIC, INC. TECHFIL 01/25/1996
K953748 TECHNIMECA MEDIC, INC. TECHNOFIL 01/25/1996


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