EMCOOLSPAD— 510(k) K100071

Name: FDA 510(k) clearance K100071
Creator: U.S. Food and Drug Administration
Published: 2010-10-12

Substantially Equivalent

Emcools Emergency Medical Cooling Systems AG

FDA 510(k) clearance K100071 for EMCOOLSPAD, Substantially Equivalent on 2010-10-12. Applicant: Emcools Emergency Medical Cooling Systems AG. Device class: 2.

Clearance details

Applicant: Emcools Emergency Medical Cooling Systems AG
Product code: Code NZE
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2010-01-11
Decision date: 2010-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vienna, AT

Download summary PDF View on FDA.gov ↗

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