Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K081670 |
Device Name |
THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK |
Applicant |
CARDINAL HEALTH 207, INC. |
22745 SAVI RANCH PARKWAY |
YORBA LINDA,
CA
92887
|
|
Applicant Contact |
ANDRE VON MULLER |
Correspondent |
CARDINAL HEALTH 207, INC. |
22745 SAVI RANCH PARKWAY |
YORBA LINDA,
CA
92887
|
|
Correspondent Contact |
ANDRE VON MULLER |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 06/13/2008 |
Decision Date | 10/09/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|