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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
Model ERGOSELECT50,100,200,400,600,1000,1100,1200
Device Name ERGOSELECT/GE
Applicant
ERGOLINE GMBH
schwarzwaldstrasse 5
tuttlingen, 
Contact andrea pecsi
Regulation Number890.5360
Classification Product Code
ISD  
Date Received07/25/2011
Decision Date 10/31/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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