BE MICRO, TREA— 510(k) K093728

Substantially Equivalent

Eb Neuro S.P.A.

FDA 510(k) clearance K093728 for BE MICRO, TREA, Substantially Equivalent on 2010-04-29. Applicant: Eb Neuro S.P.A.. Device class: 2.

Clearance details

Applicant: Eb Neuro S.P.A.
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2009-12-03
Decision date: 2010-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmel, IN, 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.