K-number	K212031
Device name	F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
Applicant	Fisher & Paykel Healthcare, Ltd.
Product code	BTT
Device class	Class II
Decision date	Apr 22, 2022
Decision	Substantially Equivalent
Regulation	868.5450

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View the full FDA submission: accessdata.fda.gov

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F&P 850 AirSpiral Adult NIV and NHF Circuit Kit

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