Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K022674 |
Device Name |
BIRD AVEA VENTILATOR |
Applicant |
BIRD PRODUCTS CORP. |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004 -1109
|
|
Applicant Contact |
JEFFREY K SHAPIRO |
Correspondent |
BIRD PRODUCTS CORP. |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004 -1109
|
|
Correspondent Contact |
JEFFREY K SHAPIRO |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 08/12/2002 |
Decision Date | 11/06/2002 |
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
|
|
|