FDA 510(k)

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator

Número K: K153045 · 2016-05-13

Data da decisão2016-05-13

Código do produtoBXN

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Easy Med Instrument Co., Ltd.. It received FDA 510(k) clearance on 2016-05-13 under 510(k) number K153045. The device is classified under product code BXN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator?

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2016-05-13. The listed applicant is Easy Med Instrument Co., Ltd.. The 510(k) number is K153045.

When did SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator receive FDA 510(k) clearance?

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator received FDA 510(k) clearance on 2016-05-13, under 510(k) number K153045.

Who is the listed applicant for SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator?

The FDA 510(k) record lists Easy Med Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator?

The FDA product code for SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator is BXN.

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Dispositivos Relacionados (Código: BXN)

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