510(k) Report

Devices descending from K891595

7 later devices reach Model 116 Fetal Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050826Fetal Ultrasound and Tocodynamometer TransducersCetro America20060—
+1K043075Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer MonitoringTenacore Holdings, Inc.20050—
+1K992811Transducers for Ultrasound and Tocodynamometer Fetal MonitoringEpic Medical Equipment Services, Inc.20002—
+1K982651Corometrics Model 5700 and 2264 Watertight TransducerCorometrics Medical Systems, Inc.19983—
+2K061044Featherlite Aqua TocodynamometerVentrex, Inc.20060—
+2K040392Transducers for Ultrasound and Tocodynamometer Fetal MonitoringAmerican I.V. Products, Inc.20040—
+2K040819Transducer for Ultrasound Fetal Monitoring, Models FM10833 and FM10834American I.V. Products, Inc.20040—