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510(k) K053078

ERGOSELECT 100 K/P, ERGOSELECT 200 K/P by Ergoline GmbH — Product Code ISD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2006
Date Received
November 2, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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  • K990866 — QUINTON MEDTRACK CR PLUS TREADMILL (April 29, 1999)
  • K990813 — REHCOR (April 12, 1999)
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