Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K820132 |
Device Name |
BABYBIRD 2 VENTILATOR |
Applicant |
3M COMPANY |
8124 PACIFIC AVE. |
WHITE CITY,
OR
97503
|
|
Correspondent |
3M COMPANY |
8124 PACIFIC AVE. |
WHITE CITY,
OR
97503
|
|
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 01/18/1982 |
Decision Date | 01/28/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|