Device Classification Name |
Percussor, Powered-Electric
|
510(k) Number |
K203209 |
Device Name |
AirPhysio Positive Expiratory Pressure (PEP) Device |
Applicant |
AirPhysio Pty Ltd |
Unit 1, 43 Greenway Drive |
Tweed Heads South,
AU
NSW 2486
|
|
Applicant Contact |
Paul O’Brien |
Correspondent |
Accelerated Device Approval Services |
6800 S.W. 40th Street, Ste. 403 |
Ludlum,
FL
33155
|
|
Correspondent Contact |
Rafael Aguila |
Regulation Number | 868.5665
|
Classification Product Code |
|
Date Received | 10/30/2020 |
Decision Date | 01/15/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|