Device Classification Name |
attachment, breathing, positive end expiratory pressure
|
510(k) Number |
K962492 |
Device Name |
SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM |
Applicant |
NIDEK MEDICAL PRODUCTS, INC. |
3949 VALLEY EAST INDUSTRIAL DR |
BIRMINGHAM,
AL
35217
|
|
Applicant Contact |
GREGG GASKINS |
Correspondent |
NIDEK MEDICAL PRODUCTS, INC. |
3949 VALLEY EAST INDUSTRIAL DR |
BIRMINGHAM,
AL
35217
|
|
Correspondent Contact |
GREGG GASKINS |
Regulation Number | 868.5965
|
Classification Product Code |
|
Date Received | 06/26/1996 |
Decision Date | 01/23/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|