FDA 510(k) Application Details - K060766

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K060766
Device Name	Electrocardiograph
Applicant	OMRON HEALTHCARE, INC. 3460 POINTE CREEK COURT #102 BONITA SPRINGS, FL 34134 US Other 510(k) Applications for this Company
Contact	DONNA DJINOVICH 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	03/22/2006
Decision Date	06/09/2006
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	Y
Expedited Review