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510(k) K121347

PRESSON ELECTRODE by Rhythmlink International, LLC — Product Code GXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2012
Date Received
May 1, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle
Device Class
Class II
Regulation Number
882.1350
Review Panel
NE
Submission Type

Other clearances by Rhythmlink International, LLC

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

Other clearances for product code GXZ

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  • K200984 — Guardian Needle Electrode (May 27, 2020)
  • K192603 — Spes Medica Subdermal Needle Electrodes (November 22, 2019)
  • K190801 — PressOn Electrode Headset (July 10, 2019)
  • K161566 — DMS Disposable Subdermal Needle Electrodes (December 21, 2016)
  • K142470 — E-Shield Multi-paried Subdermal Needle Electrodes (November 5, 2014)
  • K140200 — E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES (July 18, 2014)
  • K130220 — MR CONDITIONAL PRESSON ELECTRODE (July 22, 2013)