510(k) Report

Devices descending from K964190

9 later devices reach Era 300 Dual Chamber Pacing System Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123916Psa SeriesOsypka Medical, Inc.20130—
+1K073230Models Era 300 and 3105 Pacing System AnalyzersBiotronik, Inc.20070—
+1K050884Adapter CableRemington Medical, Inc.200501
+1K033613Modification to Era 300 Dual Chamber Pacing System AnalyzerBiotronik, Inc.20031—
+1K022360Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000…Biotronik, Inc.20034—
+2K101982Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180St Jude Medical, Crmd20100—
+2K083674PK-141 Patient CableBiotronik, Inc.20091—
+2K042708Era 3000 Pacing System AnalyzerBiotronik, Inc.20040—
+3K170815PSA CableBoston Scientific Corporation20170—