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FDA 510(k)

Arctic Sun Stat Temperature Management System

K-Number: K200225 · 2020-02-28

ApplicantMedivance, Inc.
Decision Date2020-02-28
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arctic Sun Stat Temperature Management System is the device name listed in this FDA 510(k) record. The listed applicant is Medivance, Inc.. It received FDA 510(k) clearance on 2020-02-28 under 510(k) number K200225. 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 Arctic Sun Stat Temperature Management System?

Arctic Sun Stat Temperature Management System is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Medivance, Inc.. The 510(k) number is K200225.

When did Arctic Sun Stat Temperature Management System receive FDA 510(k) clearance?

Arctic Sun Stat Temperature Management System received FDA 510(k) clearance on 2020-02-28, under 510(k) number K200225.

Who is the listed applicant for Arctic Sun Stat Temperature Management System?

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

What is the FDA product code for Arctic Sun Stat Temperature Management System?

The FDA product code for Arctic Sun Stat Temperature Management System is DWJ.

Other records listing Medivance, Inc. 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.

K251974Arctic Sun Temperature Management System (Model 5000)K243942Arctic Sun Stat Temperature Management SystemK161602Arctic Sun Temperature Management 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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