Device Classification Name |
Ventilator, Emergency, Manual (Resuscitator)
|
510(k) Number |
K912620 |
Device Name |
OPOMAT MANUAL RESUSCITATOR VENTILATOR |
Applicant |
EURO-AM PHARMA, INC. |
64 MONTROSE AVE. |
FANWOOD,
NJ
07023
|
|
Applicant Contact |
NANIK D GYAN |
Correspondent |
EURO-AM PHARMA, INC. |
64 MONTROSE AVE. |
FANWOOD,
NJ
07023
|
|
Correspondent Contact |
NANIK D GYAN |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 06/13/1991 |
Decision Date | 12/04/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|