Device Classification Name |
attachment, breathing, positive end expiratory pressure
|
510(k) Number |
K923618 |
Device Name |
PEEP VALVE |
Applicant |
INTERNATIONAL RESPIRATORY SYSTEMS, INC. |
386 BROADWAY |
2ND FLR |
NEWBURGH,
NY
12550
|
|
Applicant Contact |
SHEEHAN III |
Correspondent |
INTERNATIONAL RESPIRATORY SYSTEMS, INC. |
386 BROADWAY |
2ND FLR |
NEWBURGH,
NY
12550
|
|
Correspondent Contact |
SHEEHAN III |
Regulation Number | 868.5965
|
Classification Product Code |
|
Date Received | 07/21/1992 |
Decision Date | 08/03/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|