FDA 510(k) Application Details - K133973

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K133973
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	REMOTE DIAGNOSTIC TECHNOLOGIES LTD THE OLD COACH HOUSE, THE AVENUE, FARLEIGH WALLOP BASINGSTOKE RG252HT GB Other 510(k) Applications for this Company
Contact	LEIGH CORNOCK 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	12/26/2013
Decision Date	08/14/2014
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