FDA 510(k)

NeuroAmp II, NeuroAmp II.5s

K-Number: K193159 · 2020-12-30

Decision Date2020-12-30

Product CodeGWQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NeuroAmp II, NeuroAmp II.5s is the device name listed in this FDA 510(k) record. The listed applicant is Corscience GmbH & Co. KG. It received FDA 510(k) clearance on 2020-12-30 under 510(k) number K193159. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuroAmp II, NeuroAmp II.5s?

NeuroAmp II, NeuroAmp II.5s is a medical device that received FDA 510(k) clearance on 2020-12-30. The listed applicant is Corscience GmbH & Co. KG. The 510(k) number is K193159.

When did NeuroAmp II, NeuroAmp II.5s receive FDA 510(k) clearance?

NeuroAmp II, NeuroAmp II.5s received FDA 510(k) clearance on 2020-12-30, under 510(k) number K193159.

Who is the listed applicant for NeuroAmp II, NeuroAmp II.5s?

The FDA 510(k) record lists Corscience GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeuroAmp II, NeuroAmp II.5s?

The FDA product code for NeuroAmp II, NeuroAmp II.5s is GWQ.

Related Devices (Code: GWQ)

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.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity Sas K221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

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.