Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K073707 |
Device Name |
GE DATEX-OHMEDA AISYS |
Applicant |
DATEX-OHMEDA, INC. |
PO BOX 7550 |
MADISON,
WI
53707
|
|
Applicant Contact |
DAN KOSEDNAR |
Correspondent |
DATEX-OHMEDA, INC. |
PO BOX 7550 |
MADISON,
WI
53707
|
|
Correspondent Contact |
DAN KOSEDNAR |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 12/31/2007 |
Decision Date | 01/30/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|