8-CH Electroencephalography Amplifier— 510(k) K201747

Name: FDA 510(k) clearance K201747
Creator: U.S. Food and Drug Administration
Published: 2020-12-27

Substantially Equivalent

Hipposcreen Neurotech Corp.

FDA 510(k) clearance K201747 for 8-CH Electroencephalography Amplifier, Substantially Equivalent on 2020-12-27. Applicant: Hipposcreen Neurotech Corp.. Device class: 2.

Clearance details

Applicant: Hipposcreen Neurotech Corp.
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 2020-06-26
Decision date: 2020-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

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