510(k) K112107

BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS by Neurovirtual USA, Inc. — Product Code GWQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 28, 2011
Date Received: July 22, 2011
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Full-Montage Standard Electroencephalograph
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

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K163547 — MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 (April 11, 2017)
K131335 — BWMINI EEG, BWMINIHST, BWMINI PSG (February 3, 2015)
K062533 — BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 (December 22, 2006)

Other clearances for product code GWQ

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K220056 — iSyncWave (August 10, 2022)
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