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510(k) K200984

Guardian Needle Electrode by Rhythmlink International, LLC — Product Code GXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2020
Date Received
April 14, 2020
Clearance Type
Special
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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  • K121347 — PRESSON ELECTRODE (July 12, 2012)
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  • K112435 — RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT (September 22, 2011)

Other clearances for product code GXZ

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  • K130220 — MR CONDITIONAL PRESSON ELECTRODE (July 22, 2013)
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