510(k) Report

Devices descending from K221955

1 later device reach Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241649DUO1 and DUO2Zinnovi, Inc.20240—