CDM Insights— 510(k) K240680

Substantially Equivalent

Oxford Brain Diagnostics, Ltd.

FDA 510(k) clearance K240680 for CDM Insights, Substantially Equivalent on 2024-12-06. Applicant: Oxford Brain Diagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Oxford Brain Diagnostics, Ltd.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-03-11
Decision date: 2024-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, GB

Download summary PDF View on FDA.gov ↗

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