FDA 510(k) Application Details - K160656

Device Classification Name	Ballistocardiograph   More FDA Info for this Device
510(K) Number	K160656
Device Name	Ballistocardiograph
Applicant	CorSens Medical Ltd. 3 Azrieli Center Triangular Tower 33rd Floor 132 Menachem Begin Rd. Tel Aviv 6702301 IL Other 510(k) Applications for this Company
Contact	Yoram Levy Other 510(k) Applications for this Contact
Regulation Number	870.2320   More FDA Info for this Regulation Number
Classification Product Code	DXR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/08/2016
Decision Date	11/21/2016
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