Encevis— 510(k) K211452

Substantially Equivalent

Austrian Institute of Technology GmbH

FDA 510(k) clearance K211452 for Encevis, Substantially Equivalent on 2021-12-02. Applicant: Austrian Institute of Technology GmbH. Device class: 2.

Clearance details

Applicant: Austrian Institute of Technology GmbH
Product code: Product code OMB
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2021-05-10
Decision date: 2021-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vienna, AT

Download summary PDF View on FDA.gov ↗

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