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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 K050601
Device Name SMARTDOP 45 VASCULAR DOPPLER
Applicant
KOVEN TECHNOLOGY, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071 -3404
Applicant Contact J. HARVEY KNAUSS
Correspondent
KOVEN TECHNOLOGY, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071 -3404
Correspondent Contact J. HARVEY KNAUSS
Regulation Number870.2100
Classification Product Code
DPW  
Subsequent Product Codes
ITX   IYN  
Date Received03/09/2005
Decision Date 04/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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