Medical Device Manufacturer · IL , Netanya

Tyto Care , Ltd. - FDA 510(k) Cleared Devices

9 submissions · 8 cleared · Since 2016

Official Website

9

Total

8

Cleared

1

Denied

FDA 510(k) Regulatory Record - Tyto Care , Ltd. Anesthesiology ✕

4 devices

1-4 of 4

Cleared CT Apr 07, 2025

Tyto Insights for Rhonchi Detection

Anesthesiology · 140d

Cleared Jul 02, 2024

Tyto Insights for Crackles Detection

Anesthesiology · 125d

Cleared Dec 13, 2023

Tyto Insights for Wheeze Detection

Anesthesiology · 138d

Cleared Feb 24, 2023

TytoCare Lung Sounds Analyzer

Anesthesiology · 266d