510(k) Report

Devices descending from K221614

5 later devices reach TytoCare Lung Sounds Analyzer through their predicates, nearest generation first.

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