Arctic Sun Stat Temperature Management System

System, Thermal Regulating

Medivance, Inc.

The following data is part of a premarket notification filed by Medivance, Inc. with the FDA for Arctic Sun Stat Temperature Management System.

Pre-market Notification Details

Device IDK200225
510k NumberK200225
Device Name:Arctic Sun Stat Temperature Management System
ClassificationSystem, Thermal Regulating
Applicant Medivance, Inc. 321 South Taylor Ave, Suite 200 Louisville,  CO  80027
ContactJacquelyn Borinski
CorrespondentJacquelyn Borinski
Medivance, Inc. 321 South Taylor Ave, Suite 200 Louisville,  CO  80027
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-30
Decision Date2020-02-28

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