Device Classification Name |
Attachment, Breathing, Positive End Expiratory Pressure
|
510(k) Number |
K953511 |
Device Name |
KENDALL SHERIDAN CPAP SYSTEM |
Applicant |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
15 HAMPSHIRE ST. |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
DAVID A OLSON |
Correspondent |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
15 HAMPSHIRE ST. |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
DAVID A OLSON |
Regulation Number | 868.5965
|
Classification Product Code |
|
Date Received | 07/26/1995 |
Decision Date | 10/26/1995 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|