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510(k) K163547

MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 by Neurovirtual USA, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2017
Date Received
December 16, 2016
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 Neurovirtual USA, Inc.

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  • K112107 — BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS (October 28, 2011)
  • K062533 — BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 (December 22, 2006)

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