Arctic Sun Temperature Management System (Model 5000)
K-Number: K251974 · 2025-10-24
ApplicantMedivance, Inc.
Decision Date2025-10-24
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Arctic Sun Temperature Management System (Model 5000) is a medical device manufactured by Medivance, Inc.. It received FDA 510(k) clearance on 2025-10-24 under approval number K251974. 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 Temperature Management System (Model 5000)?
Arctic Sun Temperature Management System (Model 5000) is a medical device that received FDA 510(k) clearance on 2025-10-24. It is manufactured by Medivance, Inc.. The 510(k) number is K251974.
When was Arctic Sun Temperature Management System (Model 5000) approved by the FDA?
Arctic Sun Temperature Management System (Model 5000) received FDA 510(k) clearance on 2025-10-24, under approval number K251974.
What company makes Arctic Sun Temperature Management System (Model 5000)?
Arctic Sun Temperature Management System (Model 5000) is manufactured by Medivance, Inc..
What is the FDA product code for Arctic Sun Temperature Management System (Model 5000)?
The FDA product code for Arctic Sun Temperature Management System (Model 5000) 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.