FDA 510(k)

Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535

Número K: K192092 · 2020-01-23

Data da decisão2020-01-23

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 is the device name listed in this FDA 510(k) record. The listed applicant is Seca GmbH & Co. KG. It received FDA 510(k) clearance on 2020-01-23 under 510(k) number K192092. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535?

Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 is a medical device that received FDA 510(k) clearance on 2020-01-23. The listed applicant is Seca GmbH & Co. KG. The 510(k) number is K192092.

When did Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 receive FDA 510(k) clearance?

Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 received FDA 510(k) clearance on 2020-01-23, under 510(k) number K192092.

Who is the listed applicant for Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535?

The FDA 510(k) record lists Seca GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535?

The FDA product code for Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 is DXN.

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