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FDA 510(k)

fMRI Hardware System

K-Number: K232680 · 2023-12-13

ApplicantNordicneurolab AS
Decision Date2023-12-13
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

fMRI Hardware System is a medical device manufactured by Nordicneurolab AS. It received FDA 510(k) clearance on 2023-12-13 under approval number K232680. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the fMRI Hardware System?

fMRI Hardware System is a medical device that received FDA 510(k) clearance on 2023-12-13. It is manufactured by Nordicneurolab AS. The 510(k) number is K232680.

When was fMRI Hardware System approved by the FDA?

fMRI Hardware System received FDA 510(k) clearance on 2023-12-13, under approval number K232680.

What company makes fMRI Hardware System?

fMRI Hardware System is manufactured by Nordicneurolab AS.

What is the FDA product code for fMRI Hardware System?

The FDA product code for fMRI Hardware System is LNH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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