Cleared Traditional

K201747 - 8-CH Electroencephalography Amplifier

K201747 is an FDA 510(k) clearance for 8-CH Electroencephalography Amplifier, manufactured by Hipposcreen Neurotech Corp.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K201747

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.

GWL Device Classification - Class 2, Special Controls

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 33
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