ESOPHAGEAL COOLING DEVICE— 510(k) DEN140018

Unknown

Advanced Cooling Therapy, LLC

FDA 510(k) clearance DEN140018 for ESOPHAGEAL COOLING DEVICE, Unknown on 2015-06-23. 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: 2014-05-09
Decision date: 2015-06-23
Decision: Unknown
Clearance type: Direct
Location: Chicago, IL, US

View on FDA.gov ↗

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