Device Classification Name |
attachment, breathing, positive end expiratory pressure
|
510(k) Number |
K861758 |
Device Name |
CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA |
Applicant |
LIFE DESIGN SYSTEMS, INC. |
11017 WEST LAYTON AVE. |
MILWAUKEE,
WI
53228
|
|
Applicant Contact |
GILBERT M KIRK |
Correspondent |
LIFE DESIGN SYSTEMS, INC. |
11017 WEST LAYTON AVE. |
MILWAUKEE,
WI
53228
|
|
Correspondent Contact |
GILBERT M KIRK |
Regulation Number | 868.5965
|
Classification Product Code |
|
Date Received | 05/06/1986 |
Decision Date | 07/14/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|