510(k) Report

Devices descending from K925792

4 later devices reach Exac-Temp & Clini-Temp Tympanic & Myocardial Probe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200631DeRoyal Temperature Monitoring ProbeDeroyal Industries, Inc.20202—
+1K061942Tympanic Temperature Probe with Foam, Model M1024233; Without Foam Model M1024237GE Healthcare20060—
+2K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS…Shenzhen Med-Link Electronics Tech Co., Ltd.20260—
+2K212945Sterile Disposable Temperature ProbeShenzhen Envisen Industry Co., Ltd.20220—