FDA 510(k)

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit

Número K: K182276 · 2018-11-01

Data da decisão2018-11-01

Código do produtoDXT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Medical Care, Inc.. It received FDA 510(k) clearance on 2018-11-01 under 510(k) number K182276. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit?

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit is a medical device that received FDA 510(k) clearance on 2018-11-01. The listed applicant is Bayer Medical Care, Inc.. The 510(k) number is K182276.

When did MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit receive FDA 510(k) clearance?

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit received FDA 510(k) clearance on 2018-11-01, under 510(k) number K182276.

Who is the listed applicant for MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit?

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

What is the FDA product code for MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit?

The FDA product code for MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit is DXT.

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Outros registros que listam Bayer Medical Care, Inc. como candidato(a)

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Dispositivos Relacionados (Código: DXT)

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Fonte oficial

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