FDA 510(k) Application Details - K112601

Device Classification Name	Electrocardiograph,Ambulatory(Without Analysis)   More FDA Info for this Device
510(K) Number	K112601
Device Name	Electrocardiograph,Ambulatory(Without Analysis)
Applicant	INTRICON DATRIX CORPORATION 962 ALLEGRO LANE APOLLO BEACH, FL 33572 US Other 510(k) Applications for this Company
Contact	TANYA O'BRIEN 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	09/07/2011
Decision Date	11/09/2011
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