K-number	DEN230021
Device name	ensoETM
Applicant	Advanced Cooling Therapy, Inc. D/B/A Attune Medical
Product code	QXV
Device class	Class II
Decision date	Sep 13, 2023
Decision	Not Substantially Equivalent
Regulation	870.5720

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Source

View the full FDA submission: accessdata.fda.gov

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ensoETM

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