FDA 510(k)

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit

Número K: K180981 · 2018-09-19

RequerenteStimwave Technologies Incorporated

Data da decisão2018-09-19

Código do produtoGZB

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit is the device name listed in this FDA 510(k) record. The listed applicant is Stimwave Technologies Incorporated. It received FDA 510(k) clearance on 2018-09-19 under 510(k) number K180981. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit?

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit is a medical device that received FDA 510(k) clearance on 2018-09-19. The listed applicant is Stimwave Technologies Incorporated. The 510(k) number is K180981.

When did Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit receive FDA 510(k) clearance?

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit received FDA 510(k) clearance on 2018-09-19, under 510(k) number K180981.

Who is the listed applicant for Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit?

The FDA 510(k) record lists Stimwave Technologies Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit?

The FDA product code for Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit is GZB.

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Outros registros que listam Stimwave Technologies Incorporated como candidato(a)

K182720Freedom Spinal Cord Stimulator (SCS) System K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit K160600Sistema de Estimulador de Corda Espinhal Freedom

Dispositivos Relacionados (Código: GZB)

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Fonte oficial

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