FDA 510(k) Application Details - K963975

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K963975
Device Name	Electrode, Electrocardiograph
Applicant	VERSATEC, INC. 764 DENISON CT. P.O. BOX 7027 BLOOMFIELD HILLS, MI 48302 US Other 510(k) Applications for this Company
Contact	WILLIAM W PETERSON 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	10/03/1996
Decision Date	01/07/1997
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