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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K103637
Device Name ERKA. PERFECT-ANEROID
Applicant
Erka Kallmeyer Medizintechnik GmbH
Im Farchet 15
Bad Toelz, Bavaria,  DE 83646
Applicant Contact JAN WEISS
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact NORBERT STUIBER
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received12/13/2010
Decision Date 06/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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