FDA 510(k) Application Details - K972001

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K972001
Device Name	Electrode, Electrocardiograph
Applicant	NI MEDICAL 1601 TRAPELO RD. WALTHAM, MA 02154 US Other 510(k) Applications for this Company
Contact	BARRY SALL 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	05/30/1997
Decision Date	07/08/1997
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