Device Classification Name |
ventilator, emergency, manual (resuscitator)
|
510(k) Number |
K974141 |
Device Name |
PLUS REUSABLE RESUSCITATOR |
Applicant |
SCHIFF & CO. |
1129 BLOOMFIELD AVE. |
WEST CALDWELL,
NJ
07006
|
|
Applicant Contact |
ANNE M CESARIO |
Correspondent |
SCHIFF & CO. |
1129 BLOOMFIELD AVE. |
WEST CALDWELL,
NJ
07006
|
|
Correspondent Contact |
ANNE M CESARIO |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 11/03/1997 |
Decision Date | 05/21/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|