FDA 510(k) Application Details - K002230

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K002230
Device Name	Electrode, Electrocardiograph
Applicant	CAMBRIDGE HEART, INC. 20310 SW 48TH ST. FT. LAUDERDALE, FL 33332 US Other 510(k) Applications for this Company
Contact	JOHN GREENBAUM 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	07/24/2000
Decision Date	08/18/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review