Nerveblox— 510(k) K250818

Name: FDA 510(k) clearance K250818
Creator: U.S. Food and Drug Administration
Published: 2025-08-15

Substantially Equivalent

Smart Alfa Teknoloji San. Ve Tic. A.S.

FDA 510(k) clearance K250818 for Nerveblox, Substantially Equivalent on 2025-08-15. Applicant: Smart Alfa Teknoloji San. Ve Tic. A.S.. Device class: 2.

Clearance details

Applicant: Smart Alfa Teknoloji San. Ve Tic. A.S.
Product code: Code QRG
Device class: Class 2
Regulation: 21 CFR 868.1980
Advisory panel: Anesthesiology
Date received: 2025-03-18
Decision date: 2025-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ankara, TR

Download summary PDF View on FDA.gov ↗

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