FDA 510(k) Application Details - K221614

Device Classification Name	More FDA Info for this Device
510(K) Number	K221614
Device Name	TytoCare Lung Sounds Analyzer
Applicant	Tyto Care Ltd. 14 Beni Gaon Street Netanya 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	06/03/2022
Decision Date	02/24/2023
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