FDA 510(k) Application Details - K071631

Device Classification Name	Computer, Diagnostic, Pre-Programmed, Single-Function   More FDA Info for this Device
510(K) Number	K071631
Device Name	Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant	CHEETAH MEDICAL INC. 12154 DARNESTOWN RD. #236 GAITHERSBURG, MD 20878 US Other 510(k) Applications for this Company
Contact	Rhona Shanker Other 510(k) Applications for this Contact
Regulation Number	870.1435   More FDA Info for this Regulation Number
Classification Product Code	DXG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/14/2007
Decision Date	01/18/2008
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