510(k) Report

Devices descending from K111637

5 later devices reach Infrared Ear Thermometer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140681Belter Infra-Red Ear ThermometerShenzhen Belter Health Measurement and Analysis TE20141—
+1K120144Vital Signs MonitorEdan Instruments, Inc.20122—
+2K180314Infrared ThermometerXuzhou Yongkang Electronic Science Technology Co., Ltd.20180—
+2K131818Vital Signs MonitorEdan Instruments, Inc.201312
+3K180380vital signs monitorEdan Instruments, Inc.201801