FDA 510(k) Application Details - K142424

Device Classification Name	Electrocardiograph,Ambulatory(Without Analysis)   More FDA Info for this Device
510(K) Number	K142424
Device Name	Electrocardiograph,Ambulatory(Without Analysis)
Applicant	NORTH EAST MONITORING INC. 2 CLOCK TOWER PLACE, STE 555 MAYNARD, MA 01754 US Other 510(k) Applications for this Company
Contact	SHERRY STEELE 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	08/29/2014
Decision Date	11/25/2014
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