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510(k) K142470

E-Shield Multi-paried Subdermal Needle Electrodes by Neuroinvent, Inc. — Product Code GXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2014
Date Received
September 3, 2014
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

Other clearances by Neuroinvent, Inc.

  • K140200 — E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES (July 18, 2014)

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  • K161566 — DMS Disposable Subdermal Needle Electrodes (December 21, 2016)
  • K140200 — E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES (July 18, 2014)
  • K130220 — MR CONDITIONAL PRESSON ELECTRODE (July 22, 2013)
  • K130136 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUB (July 19, 2013)