510(k) Report

Devices descending from K073712

3 later devices reach Soft Air, Model SA 4000 and Mistral Air, Model MA0100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101705Mistral-Air Warming SystemThe Surgical Company International B.V.201021
+2K171234Mistral-Air Warming UnitThe Surgical Company International BV (As the 37company)20171—
+3K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life20260—