FDA 510(k) Application Details - K973663

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K973663
Device Name	Electrode, Electrocardiograph
Applicant	GOLDEN GATE BIO-DEVICE 22030 IDENA AVE. CASTRO VALLEY, CA 94546 US Other 510(k) Applications for this Company
Contact	MARK J HASTINGS 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	09/25/1997
Decision Date	02/10/1998
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