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FDA 510(k)

MRIaudio PREM System

K-Number: K180100 · 2018-06-14

ApplicantMriaudio
Decision Date2018-06-14
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRIaudio PREM System is a medical device manufactured by Mriaudio. It received FDA 510(k) clearance on 2018-06-14 under approval number K180100. 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 MRIaudio PREM System?

MRIaudio PREM System is a medical device that received FDA 510(k) clearance on 2018-06-14. It is manufactured by Mriaudio. The 510(k) number is K180100.

When was MRIaudio PREM System approved by the FDA?

MRIaudio PREM System received FDA 510(k) clearance on 2018-06-14, under approval number K180100.

What company makes MRIaudio PREM System?

MRIaudio PREM System is manufactured by Mriaudio.

What is the FDA product code for MRIaudio PREM System?

The FDA product code for MRIaudio PREM 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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