FDA 510(k) Application Details - K960968

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K960968
Device Name	Electrode, Electrocardiograph
Applicant	GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1271 BUAFFLO, NY 14240-1271 US Other 510(k) Applications for this Company
Contact	KATHLEEN SELOVER 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	03/11/1996
Decision Date	10/28/1996
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