510(k) Report

Devices descending from K801199

2 later devices reach Voldyne Volumetric Incentive Deep BR. EX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141355Volumetric Incentive SpirometerBesmed Health Business Corporation20141—
+2K182847Hudson RCI Voldyne Volumetric ExerciserTeleflexmedical, Inc.20190—