FDA 510(k)

Nalu Neurostimulation System

Número K: K203547 · 2021-03-25

RequerenteBoston Scientific Neuromodulation

Data da decisão2021-03-25

Código do produtoGZB

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nalu Neurostimulation System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Neuromodulation. It received FDA 510(k) clearance on 2021-03-25 under 510(k) number K203547. 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 Nalu Neurostimulation System?

Nalu Neurostimulation System is a medical device that received FDA 510(k) clearance on 2021-03-25. The listed applicant is Boston Scientific Neuromodulation. The 510(k) number is K203547.

When did Nalu Neurostimulation System receive FDA 510(k) clearance?

Nalu Neurostimulation System received FDA 510(k) clearance on 2021-03-25, under 510(k) number K203547.

Who is the listed applicant for Nalu Neurostimulation System?

The FDA 510(k) record lists Boston Scientific Neuromodulation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nalu Neurostimulation System?

The FDA product code for Nalu Neurostimulation System is GZB.

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Outros registros que listam Boston Scientific Neuromodulation como candidato(a)

K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation K232415Nalu Neurostimulation System for Peripheral Nerve Stimulation K221376Nalu Neurostimulation System K202274Kit de Neuroestimulação Nalu (lnte:gmted 40 em: Single 8/Dual 8), Kit de Neuroestimulação Nalu (Portado, 2 em: Single 8/Dual8), Gerador de Pulsos Implantável Nalu Duplo 8 Portado com 40 ern Kil, Kits de Extensão de Cabos de Teste de 40 cm/ 60 cm/60 em, Kits de Paciente e kits de substituição diversos K201618Nalu Neurostimulation SCS system K190960Nalu Lead Blank (50cm)

Ver todos os 9 dispositivos →

Dispositivos Relacionados (Código: GZB)

K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation K221376Nalu Neurostimulation SystemBoston Scientific Neuromodulation K202274Kit de Neuroestimulação Nalu (lnte:gmted 40 em: Single 8/Dual 8), Kit de Neuroestimulação Nalu (Portado, 2 em: Single 8/Dual8), Gerador de Pulsos Implantável Nalu Duplo 8 Portado com 40 ern Kil, Kits de Extensão de Cabos de Teste de 40 cm/ 60 cm/60 em, Kits de Paciente e kits de substituição diversosBoston Scientific Neuromodulation K201618Nalu Neurostimulation SCS systemBoston Scientific Neuromodulation K191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc.K190960Nalu Lead Blank (50cm)Boston Scientific Neuromodulation

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