FDA 510(k) Application Details - K003804

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K003804
Device Name	Electrode, Electrocardiograph
Applicant	NIKO MEDICAL PRODUCTS 6401 MEADOWS WEST FORT WORTH, TX 76132 US Other 510(k) Applications for this Company
Contact	RICHARD A HAMER 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	12/08/2000
Decision Date	08/30/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review