FDA 510(k)

8ch SPEEDER de Rodilla-Pie

N.º K: K162946 · 2017-01-06

Fecha de decisión2017-01-06

Código de productoMOS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

8ch Knee-Foot SPEEDER is the device name listed in this FDA 510(k) record. The listed applicant is Quality Electrodynamics, LLC. It received FDA 510(k) clearance on 2017-01-06 under 510(k) number K162946. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 8ch Knee-Foot SPEEDER?

8ch Knee-Foot SPEEDER is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is Quality Electrodynamics, LLC. The 510(k) number is K162946.

When did 8ch Knee-Foot SPEEDER receive FDA 510(k) clearance?

8ch Knee-Foot SPEEDER received FDA 510(k) clearance on 2017-01-06, under 510(k) number K162946.

Who is the listed applicant for 8ch Knee-Foot SPEEDER?

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

What is the FDA product code for 8ch Knee-Foot SPEEDER?

The FDA product code for 8ch Knee-Foot SPEEDER is MOS.

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Otros registros que enlistan a Quality Electrodynamics, LLC como solicitante

K242006SureWave Elastography (Q7000225)K223429Contour Knee K200477Flex Body Speeder K193140Flex Body SPEEDER K183111Contour 24 K181697Flex SPEEDER de Pie/Ánkle 16ch

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Dispositivos relacionados (Código: MOS)

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Fuente oficial

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