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FDA 510(k)

GEODESIC EEG SYSTEM 300

K-Number: K063797 · 2007-01-25

ApplicantElectrical Geodesics, Incorporated
Decision Date2007-01-25
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GEODESIC EEG SYSTEM 300 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 2007-01-25 under 510(k) number K063797. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEODESIC EEG SYSTEM 300?

GEODESIC EEG SYSTEM 300 is a medical device that received FDA 510(k) clearance on 2007-01-25. The listed applicant is Electrical Geodesics, Incorporated. The 510(k) number is K063797.

When did GEODESIC EEG SYSTEM 300 receive FDA 510(k) clearance?

GEODESIC EEG SYSTEM 300 received FDA 510(k) clearance on 2007-01-25, under 510(k) number K063797.

Who is the listed applicant for GEODESIC EEG SYSTEM 300?

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 300?

The FDA product code for GEODESIC EEG SYSTEM 300 is OLT.

Related Clinical Trials

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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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.

K043309GEODESIC PHOTOGRAMMETRY SYSTEMK033399GEODESIC EEG SYSTEM SERIES 100K012079GEODESIC EEG SYSTEM, MODEL 200

Related Devices (Code: OLT)

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.

K261712Ceribell EEG Analysis SoftwareCeribell, Inc.K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.K253767UB ERP SystemUniversal BrainK251881HippoMind (v1.0)HippoclinicK251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)Nihon Kohden CorporationK240593VEEGix EEG SystemNeuroServo, 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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