FDA 510(k)

StimQ Peripheral Nerve Stimulator (PNS) System

Número K: K152178 · 2016-03-11

Data da decisão2016-03-11

Código do produtoGZF

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

StimQ Peripheral Nerve Stimulator (PNS) System is the device name listed in this FDA 510(k) record. The listed applicant is Stimq, LLC. It received FDA 510(k) clearance on 2016-03-11 under 510(k) number K152178. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the StimQ Peripheral Nerve Stimulator (PNS) System?

StimQ Peripheral Nerve Stimulator (PNS) System is a medical device that received FDA 510(k) clearance on 2016-03-11. The listed applicant is Stimq, LLC. The 510(k) number is K152178.

When did StimQ Peripheral Nerve Stimulator (PNS) System receive FDA 510(k) clearance?

StimQ Peripheral Nerve Stimulator (PNS) System received FDA 510(k) clearance on 2016-03-11, under 510(k) number K152178.

Who is the listed applicant for StimQ Peripheral Nerve Stimulator (PNS) System?

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

What is the FDA product code for StimQ Peripheral Nerve Stimulator (PNS) System?

The FDA product code for StimQ Peripheral Nerve Stimulator (PNS) System is GZF.

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