TRIUX neo (NM27000N ); MEGreview (SW26241N-B)— 510(k) K233985

Name: FDA 510(k) clearance K233985
Creator: U.S. Food and Drug Administration
Published: 2024-05-15

Substantially Equivalent

Megin OY

FDA 510(k) clearance K233985 for TRIUX neo (NM27000N ); MEGreview (SW26241N-B), Substantially Equivalent on 2024-05-15. Applicant: Megin OY. Device class: 2.

Clearance details

Applicant: Megin OY
Product code: Code OLX
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2023-12-18
Decision date: 2024-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Espoo, FI

Download summary PDF View on FDA.gov ↗

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