K-number	K223696
Device name	F&P Solo Mask Range
Applicant	Fisher & Paykel Healthcare, Ltd.
Product code	BZD
Device class	Class II
Decision date	May 17, 2023
Decision	Substantially Equivalent
Regulation	868.5905

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Source

View the full FDA submission: accessdata.fda.gov

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F&P Solo Mask Range

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