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 |
| K240375 |
Shenzhen Mindray Bio-Medical Electronics Co., LTD. |
V80 Anesthetic Vaporizer (V80) |
10/31/2024 |
| 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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