Cleared Traditional

K850430 - NEUROSCIENCE MAP-10 EEG

K850430 is an FDA 510(k) clearance for NEUROSCIENCE MAP-10 EEG, manufactured by Neuroscience, Inc.. The device is a Class 1 Neurology device with product code GWS cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K850430 · Neuroscience, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1985
Decision
163d
Days
Class 1
Risk

K850430 is an FDA 510(k) clearance for the NEUROSCIENCE MAP-10 EEG. Classified as Analyzer, Spectrum, Electroencephalogram Signal (product code GWS), Class I - General Controls.

Submitted by Neuroscience, Inc. (Los Altos, US). The FDA issued a Cleared decision on July 17, 1985 after a review of 163 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1420 - 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 Neuroscience, Inc. devices

FDA 510(k) Submission Details - K850430

510(k) Number K850430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1985
Decision Date July 17, 1985
Days to Decision 163 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 148d · This submission: 163d
Pathway characteristics
Predicate-based equivalence.

GWS Device Classification - Class 1, General Controls

Product Code GWS Analyzer, Spectrum, Electroencephalogram Signal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.