FDA 510(k)

8ch SPEEDER de Joelho-Pé

Número K: K162946 · 2017-01-06

Data da decisão2017-01-06

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Quality Electrodynamics, LLC como candidato(a)

K242006SureWave Elastography (Q7000225)K223429Contour Knee K200477Flex Body Speeder K193140Flex Body SPEEDER K183111Contour 24 K18169716ch SPEEDER de Pé/ Tornozelo

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Fonte oficial

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