FDA 510(k) Application Details - K031174

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K031174
Device Name	Electrode, Electrocardiograph
Applicant	WANDY RUBBER INDUSTRIAL CO., LTD NO.24, ALLEY 37, LANE 392 FU TEH 1ST RD. SHI-CHIH 221 TW Other 510(k) Applications for this Company
Contact	JANIS YANG 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	04/14/2003
Decision Date	07/10/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review