FDA 510(k) Application Details - K100362

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K100362
Device Name	Computer, Diagnostic, Programmable
Applicant	CAMBRIDGE HEART, INC. 20310 SW 48TH ST. SOUTHWEST RANCHES, FL 33332 US Other 510(k) Applications for this Company
Contact	JOHN GREENBAUM Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2010
Decision Date	04/14/2010
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