510(k) Report

Devices descending from K981083

4 later devices reach Retrox RX 53-BP, Retrox RX 60-BP, Retrox RX 45-JBP, Retrox RX 53-JBP Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K994240EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133Biotronik, Inc.20001—
+1K990483Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777Biotronik, Inc.19991—
+2K023205Elox P 45-BP; Elox P 53-BP; Elox P 60-BPBiotronik, Inc.20030—
+2K993139YP 45/15-BP; YP 53/15-BP; YP 60/15-BPBiotronik, Inc.19990—