Cleared Traditional

K062533 - BWII EEG DIGITAL

Also marketed or referenced as:
BWII PSG DIGITAL, MODEL PV 1524

K062533 is the FDA 510(k) clearance for BWII EEG DIGITAL by Neurovirtual USA, Inc.. It is a Class 2 Neurology device (product code OLT) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K062533 · Neurovirtual USA, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
115d
Days
Class 2
Risk

K062533 is an FDA 510(k) clearance for the BWII EEG DIGITAL, MODEL PV 1652. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Neurovirtual USA, Inc. (Doral, US). The FDA issued a Cleared decision on December 22, 2006 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Neurovirtual USA, Inc. devices

Submission Details

510(k) Number K062533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2006
Decision Date December 22, 2006
Days to Decision 115 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 148d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLT Non-normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - OLT Non-normalizing Quantitative Electroencephalograph Software

All 16
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