Device Classification Name |
gas-machine, anesthesia
|
510(k) Number |
K042154 |
Device Name |
GE DATEX-OHMEDA AISYS CARESTATION |
Applicant |
DATEX-OHMEDA, INC. |
P.O. BOX 7550 |
MADISON,
WI
53707
|
|
Applicant Contact |
DAN KOSEDNAR, RAC |
Correspondent |
DATEX-OHMEDA, INC. |
P.O. BOX 7550 |
MADISON,
WI
53707
|
|
Correspondent Contact |
DAN KOSEDNAR, RAC |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 08/10/2004 |
Decision Date | 08/31/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|