FDA 510(k) Application Details - K081776

Device Classification Name	Computer, Diagnostic, Pre-Programmed, Single-Function   More FDA Info for this Device
510(K) Number	K081776
Device Name	Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant	OMEGA CRITICAL CARE LIMITED OMEGA HOUSE, 2 CAIRN COURT NERSTON WEST EAST KILBRIDE G74 4NB GB Other 510(k) Applications for this Company
Contact	ALAN SHORT 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	06/23/2008
Decision Date	07/22/2008
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