FDA 510(k) Application Details - K000206

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K000206
Device Name	Electrode, Electrocardiograph
Applicant	AXELGAARD MFG. CO., LTD. 329 WEST AVIATION RD. FALLBROOK, CA 92028-3227 US Other 510(k) Applications for this Company
Contact	DAN JEFFERY 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	01/21/2000
Decision Date	04/13/2000
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