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FDA 510(k)

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

N.º K: K192092 · 2020-01-23

SolicitanteSeca GmbH & Co. KG
Fecha de decisión2020-01-23
Código de productoDXN
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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