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510(k) K203079

MR Conditional Sticky Pad Electrode by Rhythmlink International, LLC — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2021
Date Received
October 13, 2020
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

Other clearances by Rhythmlink International, LLC

  • K200984 — Guardian Needle Electrode (May 27, 2020)
  • K191225 — EEG Electrode Template (August 5, 2019)
  • K190801 — PressOn Electrode Headset (July 10, 2019)
  • K172503 — MR Conditional Cup Electrode, MR Conditional Webb Electrode (December 1, 2017)
  • K132138 — RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE (April 11, 2014)
  • K130220 — MR CONDITIONAL PRESSON ELECTRODE (July 22, 2013)
  • 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)
  • K112435 — RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT (September 22, 2011)

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