NEURODRIVE SYSTEM— 510(k) K051830

Substantially Equivalent

Alpha Omega , Ltd.

FDA 510(k) clearance K051830 for NEURODRIVE SYSTEM, Substantially Equivalent on 2005-09-16. Applicant: Alpha Omega , Ltd.. Device class: 2.

Clearance details

Applicant: Alpha Omega , Ltd.
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 2005-07-06
Decision date: 2005-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nazareth Illit, IL

Download summary PDF View on FDA.gov ↗

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