Esophageal Cooling Device— 510(k) K170009

Name: FDA 510(k) clearance K170009
Creator: U.S. Food and Drug Administration
Published: 2017-03-30

Substantially Equivalent

Advanced Cooling Therapy, LLC

FDA 510(k) clearance K170009 for Esophageal Cooling Device, Substantially Equivalent on 2017-03-30. Applicant: Advanced Cooling Therapy, LLC. Device class: 2.

Clearance details

Applicant: Advanced Cooling Therapy, LLC
Product code: Code PLA
Device class: Class 2
Regulation: 21 CFR 870.5910
Advisory panel: Cardiovascular
Date received: 2017-01-03
Decision date: 2017-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Advanced Cooling Therapy, LLC

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