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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 K031931
Device Name ECHO SOUNDER EX-101EX 8 MHZ
Applicant
Koven Technology, Inc.
11874 S. Evelyn Cir.
Houston,  TX  77071
Applicant Contact J. HARVEY KNAUSS
Correspondent
Koven Technology, Inc.
11874 S. Evelyn Cir.
Houston,  TX  77071
Correspondent Contact J. HARVEY KNAUSS
Regulation Number870.2100
Classification Product Code
DPW  
Date Received06/23/2003
Decision Date 02/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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