Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K032803 |
Device Name |
DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM |
Applicant |
DATEX-OHMEDA |
PO BOX 7550 |
MADISON,
WI
53707
|
|
Applicant Contact |
DAN KOSEDNAR |
Correspondent |
DATEX-OHMEDA |
PO BOX 7550 |
MADISON,
WI
53707
|
|
Correspondent Contact |
DAN KOSEDNAR |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 09/09/2003 |
Decision Date | 03/10/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|