| Device Classification Name |
Attachment, Breathing, Positive End Expiratory Pressure
|
| 510(k) Number |
K882219 |
| Device Name |
P.E.E.P. VALVE |
| Applicant |
| Life Support Products, Inc. |
| One Mauchly |
|
Irvine,
CA
92718
|
|
| Applicant Contact |
TOM FANGROW |
| Correspondent |
| Life Support Products, Inc. |
| One Mauchly |
|
Irvine,
CA
92718
|
|
| Correspondent Contact |
TOM FANGROW |
| Regulation Number | 868.5965 |
| Classification Product Code |
|
| Date Received | 05/26/1988 |
| Decision Date | 08/30/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|