FDA 510(k) Application Details - K092389

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K092389
Device Name	Electrode, Electrocardiograph
Applicant	SUZUKEN CO., LTD. 3F, 2-17-6 AKEBONO-CHO TACHIKAWA-SHI, TOKYO 190-0012 JP Other 510(k) Applications for this Company
Contact	KOJI KUBO 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	08/05/2009
Decision Date	10/13/2009
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