CONDUCTIVE EEG ELECTROLYTE— 510(k) K033052

Name: FDA 510(k) clearance K033052
Creator: U.S. Food and Drug Administration
Published: 2003-12-17

Substantially Equivalent

Compumedics USA, Ltd.

FDA 510(k) clearance K033052 for CONDUCTIVE EEG ELECTROLYTE, Substantially Equivalent on 2003-12-17. Applicant: Compumedics USA, Ltd.. Device class: 2.

Clearance details

Applicant: Compumedics USA, Ltd.
Product code: Code GYB
Device class: Class 2
Regulation: 21 CFR 882.1275
Advisory panel: Neurology
Date received: 2003-09-29
Decision date: 2003-12-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: El Paso, TX, US

Download summary PDF View on FDA.gov ↗

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