NEOGENESYS 2K— 510(k) K022433

Substantially Equivalent

Sanexas Intl. GmbH

FDA 510(k) clearance K022433 for NEOGENESYS 2K, Substantially Equivalent on 2003-01-24. Applicant: Sanexas Intl. GmbH. Device class: 2.

Clearance details

Applicant: Sanexas Intl. GmbH
Product code: Code LIH
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2002-07-25
Decision date: 2003-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lee'S Summit, MO, 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.