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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 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.

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. 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.

Related Devices (Code: OLW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260907BIS™ Advance pEEG ModuleCovidien LPK260880SedLine Sedation MonitorMasimo CorporationK230693BIS™ Advance Monitoring SystemCovidien, LLCK213273Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics , Ltd.K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo CorporationK172890SedLine Sedation MonitorMasimo Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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