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FDA 510(k)

neuro42 MRI System

K-Number: K232644 · 2024-02-08

ApplicantNeuro42, Inc.
Decision Date2024-02-08
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

neuro42 MRI System is a medical device manufactured by Neuro42, Inc.. It received FDA 510(k) clearance on 2024-02-08 under approval number K232644. 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 neuro42 MRI System?

neuro42 MRI System is a medical device that received FDA 510(k) clearance on 2024-02-08. It is manufactured by Neuro42, Inc.. The 510(k) number is K232644.

When was neuro42 MRI System approved by the FDA?

neuro42 MRI System received FDA 510(k) clearance on 2024-02-08, under approval number K232644.

What company makes neuro42 MRI System?

neuro42 MRI System is manufactured by Neuro42, Inc..

What is the FDA product code for neuro42 MRI System?

The FDA product code for neuro42 MRI System is LNH.

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Official Source

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