Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K110213 |
Device Name |
GE DATEX-OHMEDA AISYS |
Applicant |
DATEX-OHMEDA, INC. |
PO BOX 7550 |
3030 OHMEDA DR. |
MADISON,
WI
53707 -7550
|
|
Applicant Contact |
JIM RASKOB |
Correspondent |
DATEX-OHMEDA, INC. |
PO BOX 7550 |
3030 OHMEDA DR. |
MADISON,
WI
53707 -7550
|
|
Correspondent Contact |
JIM RASKOB |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 01/25/2011 |
Decision Date | 07/20/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|