FDA 510(k)

MRIaudio PREM System with MRIview

Número K: K193102 · 2020-01-06

Data da decisão2020-01-06

Código do produtoLNH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

MRIaudio PREM System with MRIview is the device name listed in this FDA 510(k) record. The listed applicant is Mriaudio, Inc.. It received FDA 510(k) clearance on 2020-01-06 under 510(k) number K193102. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MRIaudio PREM System with MRIview?

MRIaudio PREM System with MRIview is a medical device that received FDA 510(k) clearance on 2020-01-06. The listed applicant is Mriaudio, Inc.. The 510(k) number is K193102.

When did MRIaudio PREM System with MRIview receive FDA 510(k) clearance?

MRIaudio PREM System with MRIview received FDA 510(k) clearance on 2020-01-06, under 510(k) number K193102.

Who is the listed applicant for MRIaudio PREM System with MRIview?

The FDA 510(k) record lists Mriaudio, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRIaudio PREM System with MRIview?

The FDA product code for MRIaudio PREM System with MRIview is LNH.

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