FDA 510(k)

SPIN-SWI

N.º K: K173224 · 2018-02-23

Fecha de decisión2018-02-23

Código de productoLNH

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

SPIN-SWI is the device name listed in this FDA 510(k) record. The listed applicant is Spintech, Inc.. It received FDA 510(k) clearance on 2018-02-23 under 510(k) number K173224. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SPIN-SWI?

SPIN-SWI is a medical device that received FDA 510(k) clearance on 2018-02-23. The listed applicant is Spintech, Inc.. The 510(k) number is K173224.

When did SPIN-SWI receive FDA 510(k) clearance?

SPIN-SWI received FDA 510(k) clearance on 2018-02-23, under 510(k) number K173224.

Who is the listed applicant for SPIN-SWI?

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

What is the FDA product code for SPIN-SWI?

The FDA product code for SPIN-SWI is LNH.

Otros registros que enlistan a Spintech, Inc. como solicitante

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.

K223079Stage K210843STAGE

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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.