FDA 510(k)

MTX-C1

Número K: K212561 · 2022-09-27

Data da decisão2022-09-27

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

MTX-C1 is the device name listed in this FDA 510(k) record. The listed applicant is Ilooda Co,., Ltd.. It received FDA 510(k) clearance on 2022-09-27 under 510(k) number K212561. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MTX-C1?

MTX-C1 is a medical device that received FDA 510(k) clearance on 2022-09-27. The listed applicant is Ilooda Co,., Ltd.. The 510(k) number is K212561.

When did MTX-C1 receive FDA 510(k) clearance?

MTX-C1 received FDA 510(k) clearance on 2022-09-27, under 510(k) number K212561.

Who is the listed applicant for MTX-C1?

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

What is the FDA product code for MTX-C1?

The FDA product code for MTX-C1 is GEI.

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Fonte oficial

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