510(k) Report

Devices descending from K843385

9 later devices reach Corometrics 115 Fetal Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013477Toco Lite, Model TD-01Ventrex, Inc.20025—
+1K992811Transducers for Ultrasound and Tocodynamometer Fetal MonitoringEpic Medical Equipment Services, Inc.20002—
+2K140163Koala TocoClinical Innovations, LLC20140—
+2K090145Surecall Emg Labor MonitorReproductive Research Technologies, LP20112—
+2K061044Featherlite Aqua TocodynamometerVentrex, Inc.20060—
+2K043075Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer MonitoringTenacore Holdings, Inc.20050—
+2K040392Transducers for Ultrasound and Tocodynamometer Fetal MonitoringAmerican I.V. Products, Inc.20040—
+3K131889Eum 100PROPromedic, Inc.20140—
+3K130002Surecall Labor MonitorReproductive Research Technologies, LP20130—