FDA 510(k) Application Details - K113306

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K113306
Device Name	Electrocardiograph
Applicant	BIONET CO., LTD. 5405 ALTON PARKWAY, SUITE A530 IRVINE, CA 92604 US Other 510(k) Applications for this Company
Contact	MARC GOODMAN 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	11/09/2011
Decision Date	07/16/2012
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