Cleared Traditional

K201747 - 8-CH Electroencephalography Amplifier

K201747 is the FDA 510(k) clearance for 8-CH Electroencephalography Amplifier by Hipposcreen Neurotech Corp.. It is a Class 2 Neurology device (product code GWL) cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K201747 · Hipposcreen Neurotech Corp. · Neurology device
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Dec 2020
Decision
184d
Days
Class 2
Risk

K201747 is an FDA 510(k) clearance for the 8-CH Electroencephalography Amplifier. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Hipposcreen Neurotech Corp. (Taipei City, TW). The FDA issued a Cleared decision on December 27, 2020 after a review of 184 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - 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 Hipposcreen Neurotech Corp. devices

Submission Details

510(k) Number K201747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2020
Decision Date December 27, 2020
Days to Decision 184 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 148d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
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 - GWL Amplifier, Physiological Signal

All 17
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K201747.
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K881177 · Nihon Kohden America, Inc. · Sep 1988