510(k) Report

Devices descending from K101705

2 later devices reach Mistral-Air Warming System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171234Mistral-Air Warming UnitThe Surgical Company International BV (As the 37company)20171—
+2K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life20260—