Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K122350 |
Device Name |
TAP PAP NASAL PILLOW MASK |
Applicant |
AIRWAY MANAGEMENT, INC. |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
AIRWAY MANAGEMENT, INC. |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 08/03/2012 |
Decision Date | 11/01/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|