Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K060862 |
Device Name |
GE DATEX-OHMEDA ENGSTROM CARESTATION |
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 | 868.5895 |
Classification Product Code |
|
Date Received | 03/29/2006 |
Decision Date | 06/05/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
Recalls |
CDRH Recalls
|
|
|