Device Classification Name |
gas-machine, anesthesia
|
510(k) Number |
K965041 |
Device Name |
OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM |
Applicant |
OHMEDA MEDICAL |
OHMEDA DRIVE, P.O. BOX 7550 |
MADISON,
WI
53707 -7550
|
|
Applicant Contact |
CHARLES MORREALE |
Correspondent |
OHMEDA MEDICAL |
OHMEDA DRIVE, P.O. BOX 7550 |
MADISON,
WI
53707 -7550
|
|
Correspondent Contact |
CHARLES MORREALE |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 12/17/1996 |
Decision Date | 06/17/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|