510(k) Report

Devices descending from K202062

6 later devices reach wheezo WheezeRate Detector through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221614TytoCare Lung Sounds AnalyzerTyto Care, Ltd.20235—
+2K232237Tyto Insights for Wheeze DetectionTyto Care, Ltd.20234—
+3K260140Aevice Wheeze Detection ModuleAevice Health Pte., Ltd.20260—
+3K252844Tyto Insights for Wheeze Detection (with PCCP)Tyto Care, Ltd.20260—
+3K240555Tyto Insights for Crackles DetectionTyto Care, Ltd.20241—
+4K243567Tyto Insights for Rhonchi DetectionTyto Care, Ltd.20250—