510(k) Report

Devices descending from K010281

2 later devices reach Merox Bipolar High Impedance Lead Models: Mex 53/13-BP; 60/15-BP; 45-JBP; 53-JBP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023099Arox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBPBiotronik, Inc.20020—
+1K021217Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBPBiotronik, Inc.20021—