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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 K040909
Device Name SONO TT ULTRASONIC FLOWCOMPUTER
Applicant
Em-Tec GmbH
Lerchenberg 20
Finning, Bavaria,  DE 86923
Applicant Contact ANDREAS KNABE
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact STEFAN PREISS
Regulation Number870.2100
Classification Product Code
DPW  
Date Received04/08/2004
Decision Date 04/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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