FDA 510(k) Application Details - K062068

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K062068
Device Name	Electrocardiograph
Applicant	INTELWAVE, LLC 1090 KING GEORGES POST ROAD SUITE 1004 EDISON, NJ 08837 US Other 510(k) Applications for this Company
Contact	ALEXANDER RIFTINE Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/21/2006
Decision Date	10/27/2006
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