510(k) Report

Devices descending from K222977

1 later device reach DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250429DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120)…Macromedics BV20250—