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510(k) K130220

MR CONDITIONAL PRESSON ELECTRODE by Rhythmlink International, LLC — Product Code GXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2013
Date Received
January 29, 2013
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

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  • K132138 — RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE (April 11, 2014)
  • 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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  • K130136 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUB (July 19, 2013)