Device Classification Name |
gas-machine, anesthesia
|
510(k) Number |
K993410 |
Device Name |
DATES-OHMEDA AESTIVA SMARTVENT MRI |
Applicant |
DATEX-OHMEDA, INC. |
OHMEDA DR. |
P.O. BOX 7550 |
MADISON,
WI
53707 -7550
|
|
Applicant Contact |
DANIEL KOSEDNAR |
Correspondent |
DATEX-OHMEDA, INC. |
OHMEDA DR. |
P.O. BOX 7550 |
MADISON,
WI
53707 -7550
|
|
Correspondent Contact |
DANIEL KOSEDNAR |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 10/12/1999 |
Decision Date | 04/25/2000 |
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
|
|
|