The IQool System
K-Number: K162523 · 2017-05-03
ApplicantBraincool AB
Decision Date2017-05-03
Product CodeNZE
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
The IQool System is a medical device manufactured by Braincool AB. It received FDA 510(k) clearance on 2017-05-03 under approval number K162523. The device is classified under product code NZE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the The IQool System?
The IQool System is a medical device that received FDA 510(k) clearance on 2017-05-03. It is manufactured by Braincool AB. The 510(k) number is K162523.
When was The IQool System approved by the FDA?
The IQool System received FDA 510(k) clearance on 2017-05-03, under approval number K162523.
What company makes The IQool System?
The IQool System is manufactured by Braincool AB.
What is the FDA product code for The IQool System?
The FDA product code for The IQool System is NZE.
Other Devices by Braincool AB
Related Devices (Code: NZE)
K231182Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management SystemZoll Circulation, Inc.
K250979Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)Zoll Circulation, Inc.
K240933CarbonCool® SystemGlobal Healthcare SG Sdn. Bhd
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.