The IQoolTM Warm System
K-Number: K180375 · 2018-05-18
ApplicantBraincool AB
Decision Date2018-05-18
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
The IQoolTM Warm System is a medical device manufactured by Braincool AB. It received FDA 510(k) clearance on 2018-05-18 under approval number K180375. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the The IQoolTM Warm System?
The IQoolTM Warm System is a medical device that received FDA 510(k) clearance on 2018-05-18. It is manufactured by Braincool AB. The 510(k) number is K180375.
When was The IQoolTM Warm System approved by the FDA?
The IQoolTM Warm System received FDA 510(k) clearance on 2018-05-18, under approval number K180375.
What company makes The IQoolTM Warm System?
The IQoolTM Warm System is manufactured by Braincool AB.
What is the FDA product code for The IQoolTM Warm System?
The FDA product code for The IQoolTM Warm System is DWJ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.