510(k) Report

Devices descending from K103097

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+2K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+3K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+3K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—