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Tyto Care , Ltd.

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories4
Latest Approval2026-03-17
TypeNumberDevice NameCodeDate
510(k) DEN250014 Tyto Insights for Eardrum Bulging Detection SHL 2026-03-17 View
510(k) K252089 Tyto Stethoscope (G3) DQD 2026-03-12 View
510(k) K243567 Tyto Insights for Rhonchi Detection PHZ 2025-04-07 View
510(k) K240555 Tyto Insights for Crackles Detection PHZ 2024-07-02 View
510(k) K232237 Tyto Insights for Wheeze Detection PHZ 2023-12-13 View
510(k) K221614 TytoCare Lung Sounds Analyzer PHZ 2023-02-24 View
510(k) K190242 Tyto Thermometer FLL 2019-03-27 View
510(k) K181612 Tyto Stethoscope (OTC) DQD 2018-12-17 View
510(k) K160401 Tyto Stethoscope DQD 2016-10-19 View