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FDA 510(k)

GEODESIC EEG SYSTEM SERIES 100

K-Number: K033399 · 2004-08-04

ApplicantElectrical Geodesics, Incorporated
Decision Date2004-08-04
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GEODESIC EEG SYSTEM SERIES 100 is the device name listed in this FDA 510(k) record. The listed applicant is Electrical Geodesics, Incorporated. It received FDA 510(k) clearance on 2004-08-04 under 510(k) number K033399. 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 GEODESIC EEG SYSTEM SERIES 100?

GEODESIC EEG SYSTEM SERIES 100 is a medical device that received FDA 510(k) clearance on 2004-08-04. The listed applicant is Electrical Geodesics, Incorporated. The 510(k) number is K033399.

When did GEODESIC EEG SYSTEM SERIES 100 receive FDA 510(k) clearance?

GEODESIC EEG SYSTEM SERIES 100 received FDA 510(k) clearance on 2004-08-04, under 510(k) number K033399.

Who is the listed applicant for GEODESIC EEG SYSTEM SERIES 100?

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

What is the FDA product code for GEODESIC EEG SYSTEM SERIES 100?

The FDA product code for GEODESIC EEG SYSTEM SERIES 100 is GWQ.

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Other records listing Electrical Geodesics, Incorporated 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.

K063797GEODESIC EEG SYSTEM 300K043309GEODESIC PHOTOGRAMMETRY SYSTEMK012079GEODESIC EEG SYSTEM, MODEL 200

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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