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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K050088
Device Name QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER
Applicant
Neoprobe Corp.
425 Metro Pl. N.,
Suite 300
Dublin,  OH  43017
Applicant Contact RODGER A BROWN
Correspondent
Neoprobe Corp.
425 Metro Pl. N.,
Suite 300
Dublin,  OH  43017
Correspondent Contact RODGER A BROWN
Regulation Number870.2100
Classification Product Code
DPW  
Date Received01/13/2005
Decision Date 02/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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