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FDA 510(k)

NeuroSENSE Monitoring System, Model NS-901

K-Number: K202621 · 2021-08-05

ApplicantNeurowave Systems, Inc.
Decision Date2021-08-05
Product CodeOLW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Neurowave Systems, Inc.. The 510(k) number is K202621.

When was NeuroSENSE Monitoring System, Model NS-901 approved by the FDA?

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

What company makes NeuroSENSE Monitoring System, Model NS-901?

NeuroSENSE Monitoring System, Model NS-901 is manufactured by Neurowave Systems, Inc..

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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Related PubMed Literature

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Official Source

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