510(k) Report

Devices descending from K161602

3 later devices reach Arctic Sun Temperature Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.20250—
+1K200225Arctic Sun Stat Temperature Management SystemMedivance, Inc.202011
+2K243942Arctic Sun Stat Temperature Management SystemMedivance, Inc.20250—