K-number	K203449
Device name	F&P Visairo NIV Mask Range
Applicant	Fisher & Paykel Healthcare, Ltd.
Product code	CBK
Device class	Class II
Decision date	Apr 14, 2021
Decision	Substantially Equivalent
Regulation	868.5895

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Source

View the full FDA submission: accessdata.fda.gov

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F&P Visairo NIV Mask Range

Everything you need for a 510(k) submission. Nothing you don't.