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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 K111730
Device Name SONOTT FLOWLAB(R)
Applicant
Em-Tec GmbH
Lerchenberg 20
Finning, Bavaria,  DE 86923
Applicant Contact BERNHARD BRAND
Correspondent
Tuv Sud America, Inc.
1775 Old Hwy. 8 NW
New Brighton,  MN  55112
Correspondent Contact NORBERT STUIBER
Regulation Number870.2100
Classification Product Code
DPW  
Subsequent Product Code
ITX  
Date Received06/20/2011
Decision Date 01/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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