Device Classification Name |
ventilator, emergency, manual (resuscitator)
|
510(k) Number |
K963848 |
Device Name |
MANUAL RESUSCITATOR |
Applicant |
OWENS-BRIGAM MEDICAL CO. |
65 HANES RD. |
NEWLAND,
NC
28657
|
|
Applicant Contact |
BILL BROOKS |
Correspondent |
OWENS-BRIGAM MEDICAL CO. |
65 HANES RD. |
NEWLAND,
NC
28657
|
|
Correspondent Contact |
BILL BROOKS |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 09/25/1996 |
Decision Date | 07/07/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|