K-number	K203209
Device name	AirPhysio Positive Expiratory Pressure (PEP) Device
Applicant	Airphysio Pty, Ltd.
Product code	BYI
Device class	Class II
Decision date	Jan 15, 2021
Decision	Substantially Equivalent
Regulation	868.5665

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Source

View the full FDA submission: accessdata.fda.gov

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AirPhysio Positive Expiratory Pressure (PEP) Device

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