K-number	K180244
Device name	EnsoETM
Applicant	Advanced Cooling Therapy, Inc. D/B/A Attune Medical
Product code	PLA
Device class	Class II
Decision date	Feb 28, 2018
Decision	Substantially Equivalent
Regulation	870.5910

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Source

View the full FDA submission: accessdata.fda.gov

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EnsoETM

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