FDA 510(k) Application Details - K083148

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K083148
Device Name	Electrode, Electrocardiograph
Applicant	BIO PROTECH, INC. 1720-26 TAEJANG 2-DONG, WONJU WOONJU-SI, GANGWON-DO KR Other 510(k) Applications for this Company
Contact	KEVIN HAN Other 510(k) Applications for this Contact
Regulation Number	870.2360   More FDA Info for this Regulation Number
Classification Product Code	DRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/24/2008
Decision Date	11/07/2008
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