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FDA 510(k)

NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701

K-Number: K092477 · 2010-10-29

ApplicantNeurowave Systems, Inc.
Decision Date2010-10-29
Product CodeOMC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 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 2010-10-29 under 510(k) number K092477. The device is classified under product code OMC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701?

NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 is a medical device that received FDA 510(k) clearance on 2010-10-29. The listed applicant is Neurowave Systems, Inc.. The 510(k) number is K092477.

When did NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 receive FDA 510(k) clearance?

NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 received FDA 510(k) clearance on 2010-10-29, under 510(k) number K092477.

Who is the listed applicant for NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701?

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 NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701?

The FDA product code for NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 is OMC.

Related Clinical Trials

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Other records listing Neurowave Systems, Inc. as applicant

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.

K202621NeuroSENSE Monitoring System, Model NS-901

Related Devices (Code: OMC)

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.

K261101Ceribell MonitorCeribell, Inc.K251550NX01 (NX01)Naox Technologies SasK251726SignalNED System (Model RE)Forest Devices, Inc.K243185REMI Remote EEG Monitoring SystemEpitelK242930Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K232779QUEX ED; QUEX SQx World, Ltd.

Official Source

View on FDA Database →

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

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