K-number	K162553
Device name	AirSpiral Heated Breathing Tube
Applicant	Fisher & Paykel Healthcare
Product code	BTT
Device class	Class II
Decision date	Dec 20, 2018
Decision	Substantially Equivalent
Regulation	868.5450

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Source

View the full FDA submission: accessdata.fda.gov

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AirSpiral Heated Breathing Tube

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