Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K081842 |
Device Name |
ENGSTROM CARESTATION, ENGSTROM PRO |
Applicant |
DATEX-OHMEDA, INC. |
P.O. BOX 7550 |
MADISON,
WI
53707
|
|
Applicant Contact |
ADRIENNE LENZ |
Correspondent |
DATEX-OHMEDA, INC. |
P.O. BOX 7550 |
MADISON,
WI
53707
|
|
Correspondent Contact |
ADRIENNE LENZ |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 06/30/2008 |
Decision Date | 10/03/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|