FDA 510(k) Application Details - K232237

Device Classification Name	More FDA Info for this Device
510(K) Number	K232237
Device Name	Tyto Insights for Wheeze Detection
Applicant	Tyto Care Ltd. 14 Beni Gaon Street Natanya 4250803 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	07/28/2023
Decision Date	12/13/2023
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