CORIS System— 510(k) DEN240018

Unknown

Nanosonics Limited

FDA 510(k) clearance DEN240018 for CORIS System, Unknown on 2025-03-19. Applicant: Nanosonics Limited. Device class: 2.

Clearance details

Applicant: Nanosonics Limited
Product code: Code SEW
Device class: Class 2
Regulation: 21 CFR 880.6994
Advisory panel: General Hospital
Date received: 2024-05-01
Decision date: 2025-03-19
Decision: Unknown
Clearance type: Direct
Location: Macquarie Park, AU

View on FDA.gov ↗

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K253267 — CORIS System2026-03-05

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