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FDA 510(k)

Maxxi Position Sensor

K-Number: K191492 · 2020-04-24

ApplicantNeurovirtual USA, Inc.
Decision Date2020-04-24
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Maxxi Position Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Neurovirtual USA, Inc.. It received FDA 510(k) clearance on 2020-04-24 under 510(k) number K191492. 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 Maxxi Position Sensor?

Maxxi Position Sensor is a medical device that received FDA 510(k) clearance on 2020-04-24. The listed applicant is Neurovirtual USA, Inc.. The 510(k) number is K191492.

When did Maxxi Position Sensor receive FDA 510(k) clearance?

Maxxi Position Sensor received FDA 510(k) clearance on 2020-04-24, under 510(k) number K191492.

Who is the listed applicant for Maxxi Position Sensor?

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

What is the FDA product code for Maxxi Position Sensor?

The FDA product code for Maxxi Position Sensor is GWQ.

Other records listing Neurovirtual USA, 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.

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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 SasK221959Q21Neurofield, 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.

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