FDA 510(k) Application Details - K982521

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K982521
Device Name	Electrode, Electrocardiograph
Applicant	LEONHARD LANG CO. ARCHENWEG 56 INNSBRUCK A-6010 AT Other 510(k) Applications for this Company
Contact	BURRHUS LANG 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	07/20/1998
Decision Date	10/26/1999
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	Y
Expedited Review