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510(k) K112121

ERGOSELECT/GE by Ergoline GmbH — Product Code ISD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2012
Date Received
July 25, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Measuring
Device Class
Class II
Regulation Number
890.5360
Review Panel
PM
Submission Type

Other clearances by Ergoline GmbH

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