Salix Central— 510(k) K243038

Substantially Equivalent

Artrya Limited

FDA 510(k) clearance K243038 for Salix Central, Substantially Equivalent on 2025-03-27. Applicant: Artrya Limited. Device class: 2.

Clearance details

Applicant: Artrya Limited
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-09-27
Decision date: 2025-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Perth, AU

Download summary PDF View on FDA.gov ↗

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