K-number	K160540
Device name	FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
Applicant	Flexicare Medical Limited.
Product code	BZE
Device class	Class II
Decision date	Jun 23, 2016
Decision	Substantially Equivalent
Regulation	868.5270

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View the full FDA submission: accessdata.fda.gov

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FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM

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