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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number868.5665
Classification Product Code
BYI  
Date Received10/30/2020
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
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