Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K802087 |
Device Name |
BABYBIRD 2 VENTILATOR |
Applicant |
BIRD PRODUCTS CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
BIRD PRODUCTS CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 09/02/1980 |
Decision Date | 10/03/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|