Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K103211 |
Device Name |
AVEA VENTILATOR |
Applicant |
CAREFUSION |
22745 SAVI RANCH PARKWAY |
YORBA LINDA,
CA
92887
|
|
Applicant Contact |
FAROKH ETEMADIEH |
Correspondent |
CAREFUSION |
22745 SAVI RANCH PARKWAY |
YORBA LINDA,
CA
92887
|
|
Correspondent Contact |
FAROKH ETEMADIEH |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 11/01/2010 |
Decision Date | 05/12/2011 |
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
|
|
|