FDA 510(k) Application Details - K162956

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K162956
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	CONTEX INTERNATIONAL TECHNOLOGIES (CANADA), INC. 2798 THAMESGATE DRIVE, UNITS 5&6 MISSISSAUGA L4T 4E8 CA Other 510(k) Applications for this Company
Contact	RICARDO RODRIGUEZ Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	MHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/24/2016
Decision Date	09/22/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review