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FDA 510(k)

BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS

K-Number: K112107 · 2011-10-28

ApplicantNeurovirtual USA, Inc.
Decision Date2011-10-28
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Neurovirtual USA, Inc.. It received FDA 510(k) clearance on 2011-10-28 under 510(k) number K112107. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS?

BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS is a medical device that received FDA 510(k) clearance on 2011-10-28. The listed applicant is Neurovirtual USA, Inc.. The 510(k) number is K112107.

When did BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS receive FDA 510(k) clearance?

BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS received FDA 510(k) clearance on 2011-10-28, under 510(k) number K112107.

Who is the listed applicant for BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS?

The FDA 510(k) record lists Neurovirtual USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS?

The FDA product code for BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS is GWQ.

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Other records listing Neurovirtual USA, Inc. as applicant

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Related Devices (Code: GWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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