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510(k) K061148

RHYTHMLINK DISC ELECTRODES by Rhythmlink International, LLC — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2006
Date Received
April 25, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

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  • K130287 — MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE (May 30, 2013)
  • K121347 — PRESSON ELECTRODE (July 12, 2012)
  • K120342 — EMG RECORDING ELECTRODE ASSEMBLY (June 22, 2012)

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