FDA 510(k)

Trackit T4 EEG Amplifier

K-Number: K172271 · 2018-05-04

Decision Date2018-05-04

Product CodeGWQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Trackit T4 EEG Amplifier is the device name listed in this FDA 510(k) record. The listed applicant is Lifelines , Ltd.. It received FDA 510(k) clearance on 2018-05-04 under 510(k) number K172271. 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 Trackit T4 EEG Amplifier?

Trackit T4 EEG Amplifier is a medical device that received FDA 510(k) clearance on 2018-05-04. The listed applicant is Lifelines , Ltd.. The 510(k) number is K172271.

When did Trackit T4 EEG Amplifier receive FDA 510(k) clearance?

Trackit T4 EEG Amplifier received FDA 510(k) clearance on 2018-05-04, under 510(k) number K172271.

Who is the listed applicant for Trackit T4 EEG Amplifier?

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

What is the FDA product code for Trackit T4 EEG Amplifier?

The FDA product code for Trackit T4 EEG Amplifier 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.