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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Braincool AB. It received FDA 510(k) clearance on 2018-05-18 under 510(k) 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. The listed applicant is Braincool AB. The 510(k) number is K180375.

When did The IQoolTM Warm System receive FDA 510(k) clearance?

The IQoolTM Warm System received FDA 510(k) clearance on 2018-05-18, under 510(k) number K180375.

Who is the listed applicant for The IQoolTM Warm System?

The FDA 510(k) record lists Braincool AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The IQoolTM Warm System?

The FDA product code for The IQoolTM Warm System is DWJ.

Other records listing Braincool AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232844The IQoolTM SystemK162523The IQool System

Related Devices (Code: DWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC LifeK260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbHK260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.K242964Celsi WarmerHadleigh Health Technologies

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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