Device Classification Name |
gas-machine, anesthesia
|
510(k) Number |
K143530 |
Device Name |
Aespire View |
Applicant |
Datex-Ohmeda, Inc. |
3030 Ohmeda Drive |
P.O.Box7550 |
Madison,
WI
53707
|
|
Applicant Contact |
Michelle Huettner |
Correspondent |
Datex-Ohmeda, Inc. |
3030 Ohmeda Drive |
P.O.Box7550 |
Madison,
WI
53707
|
|
Correspondent Contact |
Michelle Huettner |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 12/12/2014 |
Decision Date | 04/24/2015 |
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
|
|
|