Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K172045 |
Device Name |
Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 |
Applicant |
Datex-Ohmeda, Inc. |
3030 Ohmeda Drive, PO Box 7550 |
Madison,
WI
53707 -7550
|
|
Applicant Contact |
Trishia Mercier |
Correspondent |
Datex-Ohmeda, Inc. |
3030 Ohmeda Drive, PO Box 7550 |
Madison,
WI
53707 -7550
|
|
Correspondent Contact |
Trishia Mercier |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 07/06/2017 |
Decision Date | 11/03/2017 |
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
|
|
|