Device Classification Name |
Intraoral Pressure Gradient Device
|
510(k) Number |
K122130 |
Device Name |
WINX SLEEP THERAPY SYSTEM |
Applicant |
APNICURE, INC. |
900 CHESAPEAKE DR |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
CHRIS DANIEL |
Correspondent |
APNICURE, INC. |
900 CHESAPEAKE DR |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
CHRIS DANIEL |
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 07/18/2012 |
Decision Date | 10/31/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|