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FDA 510(k)

BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524

K-Number: K062533 · 2006-12-22

ApplicantNeurovirtual USA, Inc.
Decision Date2006-12-22
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 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 2006-12-22 under 510(k) number K062533. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524?

BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 is a medical device that received FDA 510(k) clearance on 2006-12-22. The listed applicant is Neurovirtual USA, Inc.. The 510(k) number is K062533.

When did BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 receive FDA 510(k) clearance?

BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 received FDA 510(k) clearance on 2006-12-22, under 510(k) number K062533.

Who is the listed applicant for BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524?

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 BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524?

The FDA product code for BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 is OLT.

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Related Devices (Code: OLT)

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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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