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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name exerciser, measuring
510(k) Number K112121
Device Name ERGOSELECT/GE
Applicant
ERGOLINE GMBH
SCHWARZWALDSTRASSE 5
TUTTLINGEN,  DE 78532
Applicant Contact ANDREA PECSI
Correspondent
ERGOLINE GMBH
SCHWARZWALDSTRASSE 5
TUTTLINGEN,  DE 78532
Correspondent Contact ANDREA PECSI
Regulation Number890.5360
Classification Product Code
ISD  
Date Received07/25/2011
Decision Date 10/31/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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