BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524— 510(k) K062533

Name: FDA 510(k) clearance K062533
Creator: U.S. Food and Drug Administration
Published: 2006-12-22

Substantially Equivalent

Neurovirtual USA, Inc.

FDA 510(k) clearance K062533 for BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524, Substantially Equivalent on 2006-12-22. Applicant: Neurovirtual USA, Inc.. Device class: 2.

Clearance details

Applicant: Neurovirtual USA, Inc.
Product code: Code OLT
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2006-08-29
Decision date: 2006-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Doral, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OLT

product code OLT

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.