510(k) Report

Devices descending from K071955

17 later devices reach Wim-PC, Model 1010 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102229Pulmotrack 2020 SystemKarmelsonix20110—
+1K101022Pulmotrack 5050 Wholter, Model 5050Karmelsonix20106—
+1K090863Personal WheezometerKarmelsonix20098—
+2K131285SonosentryIsonea, Ltd.20147—
+2K110525Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd.20115—
+3K253293VitaloJAK Clinic (Model 7100)Vitalograph, Ltd.20250—
+3K202062wheezo WheezeRate DetectorRespiri Limited20216—
+3K201077Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs20203—
+4K221614TytoCare Lung Sounds AnalyzerTyto Care, Ltd.20235—
+4K220893Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs, Inc.20222—
+5K232237Tyto Insights for Wheeze DetectionTyto Care, Ltd.20234—
+5K223382AeviceMDAevice Health Pte., Ltd.20231—
+6K260140Aevice Wheeze Detection ModuleAevice Health Pte., Ltd.20260—
+6K252844Tyto Insights for Wheeze Detection (with PCCP)Tyto Care, Ltd.20260—
+6K243603AeviceMDAevice Health Pte., Ltd.20250—
+6K240555Tyto Insights for Crackles DetectionTyto Care, Ltd.20241—
+7K243567Tyto Insights for Rhonchi DetectionTyto Care, Ltd.20250—