COMPUMEDICS NEUVO— 510(k) K081151

Substantially Equivalent

Compumedics USA, Ltd.

FDA 510(k) clearance K081151 for COMPUMEDICS NEUVO, Substantially Equivalent on 2008-09-08. Applicant: Compumedics USA, Ltd.. Device class: 2.

Clearance details

Applicant: Compumedics USA, Ltd.
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2008-04-23
Decision date: 2008-09-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Charlotte, NC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.