Arctic Sun Stat Temperature Management System
K-Number: K243942 · 2025-04-30
ApplicantMedivance, Inc.
Decision Date2025-04-30
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Arctic Sun Stat Temperature Management System is a medical device manufactured by Medivance, Inc.. It received FDA 510(k) clearance on 2025-04-30 under approval number K243942. 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 2025-04-30. It is manufactured by Medivance, Inc.. The 510(k) number is K243942.
When was Arctic Sun Stat Temperature Management System approved by the FDA?
Arctic Sun Stat Temperature Management System received FDA 510(k) clearance on 2025-04-30, under approval number K243942.
What company makes Arctic Sun Stat Temperature Management System?
Arctic Sun Stat Temperature Management System is manufactured by Medivance, Inc..
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.
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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.