BNA ANALYSIS SYSTEM— 510(k) K121119

Substantially Equivalent

Eiminda , Ltd.

FDA 510(k) clearance K121119 for BNA ANALYSIS SYSTEM, Substantially Equivalent on 2014-07-25. Applicant: Eiminda , Ltd.. Device class: 2.

Clearance details

Applicant: Eiminda , Ltd.
Product code: Code OLU
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2012-04-12
Decision date: 2014-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herzliya, 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.