FDA 510(k) Application Details - K160956

Device Classification Name	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K160956
Device Name	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant	LD TECHNOLOGY LLC 100N. Biscayne Blvd, suite 500 Miami, FL 33132 US Other 510(k) Applications for this Company
Contact	Albert MAAREK Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	MWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2016
Decision Date	07/06/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review