FDA.report

510(k) K243942

Device
Arctic Sun Stat Temperature Management System
Applicant
Medivance, Inc.
510(k) number
K243942
Product code
DWJ
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-30
Date received
2024-12-20
Regulation
870.5900
Classification name
System, Thermal Regulating
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Lauren Valdes
Address
321 S. Taylor Ave. Suite 200 Louisville CO US 80027 80027

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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