Device Classification Name |
Attachment, Breathing, Positive End Expiratory Pressure
|
510(k) Number |
K851396 |
Device Name |
SANDER'S MASKCPAP BY RESPIRONICS |
Applicant |
RESPIRONICS, INC. |
530 SECO RD. |
MONROEVILLE,
PA
15146
|
|
Applicant Contact |
EUGENE N SCARBERRY |
Correspondent |
RESPIRONICS, INC. |
530 SECO RD. |
MONROEVILLE,
PA
15146
|
|
Correspondent Contact |
EUGENE N SCARBERRY |
Regulation Number | 868.5965
|
Classification Product Code |
|
Date Received | 04/09/1985 |
Decision Date | 05/15/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|