Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K013642 |
Device Name |
AVEA |
Applicant |
BIRD PRODUCTS CORP. |
1100 BIRD CENTER DR. |
PALM SPRINGS,
CA
92262
|
|
Applicant Contact |
TOM GUTIERREZ |
Correspondent |
BIRD PRODUCTS CORP. |
1100 BIRD CENTER DR. |
PALM SPRINGS,
CA
92262
|
|
Correspondent Contact |
TOM GUTIERREZ |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 11/05/2001 |
Decision Date | 05/22/2002 |
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
|
|
|