FDA 510(k) Application Details - K152973

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K152973
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	Techmedic Development International B.V. Broeker Werf 6 Broek op Langedijk 1721 PC NL Other 510(k) Applications for this Company
Contact	Rutger Brest van Kempen 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	10/08/2015
Decision Date	04/29/2016
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