Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K912619 |
Device Name |
BEAR 7 VENTILATOR |
Applicant |
BEAR MEDICAL SYSTEMS, INC. |
2085 RUSTIN AVE. |
RIVERSIDE,
CA
92507
|
|
Applicant Contact |
LEE ADAIR |
Correspondent |
BEAR MEDICAL SYSTEMS, INC. |
2085 RUSTIN AVE. |
RIVERSIDE,
CA
92507
|
|
Correspondent Contact |
LEE ADAIR |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 06/13/1991 |
Decision Date | 06/11/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|