FDA 510(k) Application Details - K243567

Device Classification Name	More FDA Info for this Device
510(K) Number	K243567
Device Name	Tyto Insights for Rhonchi Detection
Applicant	Tyto Care Ltd. 14 Beni Gaon Street Netanya IL Other 510(k) Applications for this Company
Contact	Stella Raizelman Perry Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2024
Decision Date	04/07/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review