FDA 510(k)

PREMIUM - SHELTA Prosthetic Components

Número K: K162028 · 2017-03-24

Data da decisão2017-03-24

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

PREMIUM - SHELTA Prosthetic Components is the device name listed in this FDA 510(k) record. The listed applicant is Sweden & Martina S.P.A.. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K162028. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PREMIUM - SHELTA Prosthetic Components?

PREMIUM - SHELTA Prosthetic Components is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Sweden & Martina S.P.A.. The 510(k) number is K162028.

When did PREMIUM - SHELTA Prosthetic Components receive FDA 510(k) clearance?

PREMIUM - SHELTA Prosthetic Components received FDA 510(k) clearance on 2017-03-24, under 510(k) number K162028.

Who is the listed applicant for PREMIUM - SHELTA Prosthetic Components?

The FDA 510(k) record lists Sweden & Martina S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREMIUM - SHELTA Prosthetic Components?

The FDA product code for PREMIUM - SHELTA Prosthetic Components is NHA.

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Outros registros que listam Sweden & Martina S.P.A. como candidato(a)

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Fonte oficial

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