Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K092864 |
Device Name |
AESPIRE 7900, AESPIRE VIEW |
Applicant |
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C |
PO BOX 7550 |
3030 OHMEDA DRIVE |
MADISON,
WI
53707 -7550
|
|
Applicant Contact |
ADRIENNE LENZ |
Correspondent |
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C |
PO BOX 7550 |
3030 OHMEDA DRIVE |
MADISON,
WI
53707 -7550
|
|
Correspondent Contact |
ADRIENNE LENZ |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 09/17/2009 |
Decision Date | 01/12/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|