TWIN NEUROTRAC-III— 510(k) K081551

Substantially Equivalent

Astro-Med, Inc.

FDA 510(k) clearance K081551 for TWIN NEUROTRAC-III, Substantially Equivalent on 2008-12-24. Applicant: Astro-Med, Inc.. Device class: 2.

Clearance details

Applicant: Astro-Med, Inc.
Product code: Code OMA
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2008-06-03
Decision date: 2008-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Warwick, RI, 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.