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510(k) K172503

MR Conditional Cup Electrode, MR Conditional Webb Electrode by Rhythmlink International, LLC — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2017
Date Received
August 18, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
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  • K120342 — EMG RECORDING ELECTRODE ASSEMBLY (June 22, 2012)
  • K112435 — RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT (September 22, 2011)

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