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 |
K861839 |
SOUTHMEDIC, INC. |
VAPOFIL |
05/21/1986 |
K945993 |
SOUTHMEDIC, INC. |
VAPOFIL |
02/22/1995 |
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 |
|
|