K-number	K223684
Device name	F&P 820 Humidification System
Applicant	Fisher & Paykel Healthcare, Ltd.
Product code	BTT
Device class	Class II
Decision date	Sep 5, 2023
Decision	Substantially Equivalent
Regulation	868.5450

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Source

View the full FDA submission: accessdata.fda.gov

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F&P 820 Humidification System

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