K-number	K234053
Device name	F&P Optiflow Flow Diverter
Applicant	Fisher & Paykel Healthcare, Ltd.
Product code	CBP
Device class	Class II
Decision date	Aug 9, 2024
Decision	Substantially Equivalent
Regulation	868.5870

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Source

View the full FDA submission: accessdata.fda.gov

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F&P Optiflow Flow Diverter

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