Device Classification Name |
ventilator, emergency, manual (resuscitator)
|
510(k) Number |
K973106 |
Device Name |
GOLEMB DISPOSABLE BAG MASK RESUSCITATOR |
Applicant |
ALLIED HEALTHCARE PRODUCTS, INC. |
1720 SUBLETTE AVE. |
ST. LOUIS,
MO
63110
|
|
Applicant Contact |
VERNON TRIMBLE |
Correspondent |
ALLIED HEALTHCARE PRODUCTS, INC. |
1720 SUBLETTE AVE. |
ST. LOUIS,
MO
63110
|
|
Correspondent Contact |
VERNON TRIMBLE |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 08/19/1997 |
Decision Date | 01/29/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|