FDA 510(k)

Triton Cage

Número K: K183407 · 2019-08-30

Data da decisão2019-08-30

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Triton Cage is the device name listed in this FDA 510(k) record. The listed applicant is Medyssey USA, Inc.. It received FDA 510(k) clearance on 2019-08-30 under 510(k) number K183407. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Triton Cage?

Triton Cage is a medical device that received FDA 510(k) clearance on 2019-08-30. The listed applicant is Medyssey USA, Inc.. The 510(k) number is K183407.

When did Triton Cage receive FDA 510(k) clearance?

Triton Cage received FDA 510(k) clearance on 2019-08-30, under 510(k) number K183407.

Who is the listed applicant for Triton Cage?

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

What is the FDA product code for Triton Cage?

The FDA product code for Triton Cage is MAX.

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Fonte oficial

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