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FDA 510(k)

The IQoolTM System

K-Number: K232844 · 2023-10-04

ApplicantBraincool AB
Decision Date2023-10-04
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

The IQoolTM System is a medical device manufactured by Braincool AB. It received FDA 510(k) clearance on 2023-10-04 under approval number K232844. 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 System?

The IQoolTM System is a medical device that received FDA 510(k) clearance on 2023-10-04. It is manufactured by Braincool AB. The 510(k) number is K232844.

When was The IQoolTM System approved by the FDA?

The IQoolTM System received FDA 510(k) clearance on 2023-10-04, under approval number K232844.

What company makes The IQoolTM System?

The IQoolTM System is manufactured by Braincool AB.

What is the FDA product code for The IQoolTM System?

The FDA product code for The IQoolTM System is DWJ.

Other Devices by Braincool AB

K162523The IQool System K180375The IQoolTM Warm System DEN210027The Cooral System

Related Devices (Code: DWJ)

K152266Altrix Precision Temperature Management SystemStryker Medical K161602Arctic Sun Temperature Management SystemMedivance, Inc. K1713733M Bair Hugger Model 675 Total Temperature Management System3M Company K171149Altrix Temperature Management WrapsStryker Medical K171234Mistral-Air Warming UnitThe Surgical Company International BV (As the 37company) K162679IOB Temperature Management SystemIob Medical, Inc.

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.

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