FDA 510(k)

NeuroSENSE Monitoring System, Model NS-901

Número K: K202621 · 2021-08-05

Data da decisão2021-08-05

Código do produtoOLW

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

NeuroSENSE Monitoring System, Model NS-901 is the device name listed in this FDA 510(k) record. The listed applicant is Neurowave Systems, Inc.. It received FDA 510(k) clearance on 2021-08-05 under 510(k) number K202621. The device is classified under product code OLW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NeuroSENSE Monitoring System, Model NS-901?

NeuroSENSE Monitoring System, Model NS-901 is a medical device that received FDA 510(k) clearance on 2021-08-05. The listed applicant is Neurowave Systems, Inc.. The 510(k) number is K202621.

When did NeuroSENSE Monitoring System, Model NS-901 receive FDA 510(k) clearance?

NeuroSENSE Monitoring System, Model NS-901 received FDA 510(k) clearance on 2021-08-05, under 510(k) number K202621.

Who is the listed applicant for NeuroSENSE Monitoring System, Model NS-901?

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

What is the FDA product code for NeuroSENSE Monitoring System, Model NS-901?

The FDA product code for NeuroSENSE Monitoring System, Model NS-901 is OLW.

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