encevis (2.1)— 510(k) K240993

Name: FDA 510(k) clearance K240993
Creator: U.S. Food and Drug Administration
Published: 2024-09-27

Substantially Equivalent

Ait Austrian Institute of Technology GmbH

FDA 510(k) clearance K240993 for encevis (2.1), Substantially Equivalent on 2024-09-27. Applicant: Ait Austrian Institute of Technology GmbH. Device class: 2.

Clearance details

Applicant: Ait Austrian Institute of Technology GmbH
Product code: Product code OMB
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2024-04-11
Decision date: 2024-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vienna, AT

Download summary PDF View on FDA.gov ↗

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