FDA 510(k) Application Details - K152626

Device Classification Name	Electrocardiograph,Ambulatory(Without Analysis)   More FDA Info for this Device
510(K) Number	K152626
Device Name	Electrocardiograph,Ambulatory(Without Analysis)
Applicant	MORTARA INSTRUMENT, INC 7865 NORTH 86TH ST. MILWAUKEE, WI 53224 US Other 510(k) Applications for this Company
Contact	Margaret Mucha Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	MWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2015
Decision Date	02/26/2016
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