FDA 510(k)

Meridian Vaginal Positioning System (VPS)

Número K: K173501 · 2018-02-09

Data da decisão2018-02-09

Código do produtoPWK

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Meridian Vaginal Positioning System (VPS) is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K173501. The device is classified under product code PWK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Meridian Vaginal Positioning System (VPS)?

Meridian Vaginal Positioning System (VPS) is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Coloplast. The 510(k) number is K173501.

When did Meridian Vaginal Positioning System (VPS) receive FDA 510(k) clearance?

Meridian Vaginal Positioning System (VPS) received FDA 510(k) clearance on 2018-02-09, under 510(k) number K173501.

Who is the listed applicant for Meridian Vaginal Positioning System (VPS)?

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

What is the FDA product code for Meridian Vaginal Positioning System (VPS)?

The FDA product code for Meridian Vaginal Positioning System (VPS) is PWK.

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Fonte oficial

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