Device Classification Name |
gas-machine, anesthesia
|
510(k) Number |
K000706 |
Device Name |
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR |
Applicant |
DATEX-OHMEDA, INC. |
OHMEDA DR. |
MADISON,
WI
53707
|
|
Applicant Contact |
DANIEL KOSEDNAR |
Correspondent |
DATEX-OHMEDA, INC. |
OHMEDA DR. |
MADISON,
WI
53707
|
|
Correspondent Contact |
DANIEL KOSEDNAR |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 03/02/2000 |
Decision Date | 05/11/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|