510(k) Report

Devices descending from K834464

3 later devices reach TDX Procainamide through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K962269Cedia Cardiac TDM Multi-CalsBoehringer Mannheim Corp.19961—
+1K962099Cedia Procainamide AssayBoehringer Mannheim Corp.19960—
+2K972433Cedia Digoxin CalibratorsBoehringer Mannheim Corp.19970—