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FDA 510(k)

CDM Insights

K-Number: K240680 · 2024-12-06

ApplicantOxford Brain Diagnostics, Ltd.
Decision Date2024-12-06
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CDM Insights is a medical device manufactured by Oxford Brain Diagnostics, Ltd.. It received FDA 510(k) clearance on 2024-12-06 under approval number K240680. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CDM Insights?

CDM Insights is a medical device that received FDA 510(k) clearance on 2024-12-06. It is manufactured by Oxford Brain Diagnostics, Ltd.. The 510(k) number is K240680.

When was CDM Insights approved by the FDA?

CDM Insights received FDA 510(k) clearance on 2024-12-06, under approval number K240680.

What company makes CDM Insights?

CDM Insights is manufactured by Oxford Brain Diagnostics, Ltd..

What is the FDA product code for CDM Insights?

The FDA product code for CDM Insights is QIH.

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Official Source

View on FDA Database →

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