EnsoETM— 510(k) K180742

Name: FDA 510(k) clearance K180742
Creator: U.S. Food and Drug Administration
Published: 2018-05-17

Substantially Equivalent

Advanced Cooling Therapy, Inc. D/B/A Attune Medical

FDA 510(k) clearance K180742 for EnsoETM, Substantially Equivalent on 2018-05-17. Applicant: Advanced Cooling Therapy, Inc. D/B/A Attune Medical. Device class: 2.

Clearance details

Applicant: Advanced Cooling Therapy, Inc. D/B/A Attune Medical
Product code: Code PLA
Device class: Class 2
Regulation: 21 CFR 870.5910
Advisory panel: Cardiovascular
Date received: 2018-03-22
Decision date: 2018-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.