Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K841279 |
Device Name |
BEAR 33 |
Applicant |
BEAR MEDICAL SYSTEMS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
BEAR MEDICAL SYSTEMS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 03/28/1984 |
Decision Date | 05/23/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|