K-number	K163300
Device name	ThermoShield HME Filter
Applicant	Flexicare Medical Limited.
Product code	CAH
Device class	Class II
Decision date	Mar 22, 2017
Decision	Substantially Equivalent
Regulation	868.5260

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Source

View the full FDA submission: accessdata.fda.gov

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ThermoShield HME Filter

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