FDA 510(k) Application Details - K160401

Device Classification Name	Stethoscope, Electronic   More FDA Info for this Device
510(K) Number	K160401
Device Name	Stethoscope, Electronic
Applicant	Tyto Care Ltd. Haomanut 12 Netanya 4205445 IL Other 510(k) Applications for this Company
Contact	Yoni Iger Other 510(k) Applications for this Contact
Regulation Number	870.1875   More FDA Info for this Regulation Number
Classification Product Code	DQD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2016
Decision Date	10/19/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review