FDA 510(k)

LL TENS 160A, LL TENS 160B

Número K: K152374 · 2016-01-13

Data da decisão2016-01-13

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

LL TENS 160A, LL TENS 160B is the device name listed in this FDA 510(k) record. The listed applicant is Fuji Dynamics , Ltd.. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K152374. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LL TENS 160A, LL TENS 160B?

LL TENS 160A, LL TENS 160B is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Fuji Dynamics , Ltd.. The 510(k) number is K152374.

When did LL TENS 160A, LL TENS 160B receive FDA 510(k) clearance?

LL TENS 160A, LL TENS 160B received FDA 510(k) clearance on 2016-01-13, under 510(k) number K152374.

Who is the listed applicant for LL TENS 160A, LL TENS 160B?

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

What is the FDA product code for LL TENS 160A, LL TENS 160B?

The FDA product code for LL TENS 160A, LL TENS 160B is NUH.

Outros registros que listam Fuji Dynamics , Ltd. como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K161055Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 K152676FD TENS 2090, FD TENS 2095

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