FDA 510(k) Application Details - K961643

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K961643
Device Name	Electrode, Electrocardiograph
Applicant	MEDICOTEST, INC. ONE METROPOLITAN SQUARE 211 NORTH BROADWAY, SUITE 3600 ST. LOUIS, MO 63102 US Other 510(k) Applications for this Company
Contact	RANDY R MARIANI 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	04/29/1996
Decision Date	12/09/1996
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