The IQool System— 510(k) K162523

Substantially Equivalent

Braincool AB

FDA 510(k) clearance K162523 for The IQool System, Substantially Equivalent on 2017-05-03. Applicant: Braincool AB.

Clearance details

Applicant: Braincool AB
Product code: Code NZE
Advisory panel: Cardiovascular
Date received: 2016-09-09
Decision date: 2017-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medicon Village, SE

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