ELECTRICAL GEODESICS, INC.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Full-Montage Standard Electroencephalograph (GWQ) (4) Source Localization Software For Electroencephalograph Or Magnetoencephalograph (OLX) (1)

Premarket Exempt

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Geodesic EEG System - 00863003000305 Catalog Number :

Device Description : Electroencephalograph

Device Class : 2

Duns Number: 809845365

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Geodesic Photogrammetry System - 00863003000312 Catalog Number :

Device Description : Full-montage Standard ElectroencephalographCAMERA, SURGICAL AND ACCESSORIES

Device Class : 2

Duns Number: 809845365

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

HydroCel Geodesic Sensor Net - 00863003000329 Catalog Number :

Device Description : EEG Electrode Array

Device Class : 2

Duns Number: 809845365

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

MicroCel Geodesic Sensor Net - 00863003000336 Catalog Number :

Device Description : EEG Electrode Array

Device Class : 2

Duns Number: 809845365

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

GeoSource - 00863003000343 Catalog Number :

Device Description : Source Localization Software For Electroencephalograph Or Magnetoencephalograph Source Localization Software For Electroencephalograph Or Magnetoencephalograph Electroencephalograph.

Device Class : 2

Duns Number: 809845365

Premarket Exempt : No

Product Code : OLX

Prescription Use : Yes

Device Count : 1

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