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FDA 510(k)

80 CHANNEL EEG

K-Number: K014147 · 2002-01-14

ApplicantXltek
Decision Date2002-01-14
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

80 CHANNEL EEG is the device name listed in this FDA 510(k) record. The listed applicant is Xltek. It received FDA 510(k) clearance on 2002-01-14 under 510(k) number K014147. 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 80 CHANNEL EEG?

80 CHANNEL EEG is a medical device that received FDA 510(k) clearance on 2002-01-14. The listed applicant is Xltek. The 510(k) number is K014147.

When did 80 CHANNEL EEG receive FDA 510(k) clearance?

80 CHANNEL EEG received FDA 510(k) clearance on 2002-01-14, under 510(k) number K014147.

Who is the listed applicant for 80 CHANNEL EEG?

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

What is the FDA product code for 80 CHANNEL EEG?

The FDA product code for 80 CHANNEL EEG is GWQ.

Related Clinical Trials

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Other records listing Xltek 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.

K01414684 CHANNEL EEGK002969XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8

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

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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