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510(k) K203209

AirPhysio Positive Expiratory Pressure (PEP) Device by Airphysio Pty, Ltd. — Product Code BYI

K203209 is an FDA 510(k) premarket notification submitted by Airphysio Pty, Ltd. for the device "AirPhysio Positive Expiratory Pressure (PEP) Device". The FDA issued a decision of Substantially Equivalent on January 15, 2021. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2021
Date Received
October 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Percussor, Powered-Electric
Device Class
Class II
Regulation Number
868.5665
Review Panel
AN
Submission Type

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FDA data resources