CERIBELL, INC.

Address:360 N Pastoria Ave,Sunnyvale,CA,94085,US

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Filters

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) (5) Reduced- Montage Standard Electroencephalograph (OMC) (3) Electrode, Cutaneous (GXY) (2) Automatic Event Detection Software For Full-Montage Electroencephalograph (OMB) (1)

Premarket Exempt

Clear

Pocket EEG Device - 00851420007007 Catalog Number :

Device Class : 2

Duns Number: 079897397

Premarket Exempt : No

Product Code : GWQ, OMC

Prescription Use : Yes

Device Count : 1

Ceribell EEG Headband, small size - 00851420007021 Catalog Number :

Device Class : 2

Duns Number: 079897397

Premarket Exempt : No

Product Code : GWQ, GXY

Prescription Use : Yes

Device Count : 1

Ceribell EEG Headband, medium size - 00851420007038 Catalog Number :

Device Class : 2

Duns Number: 079897397

Premarket Exempt : No

Product Code : GXY, GWQ

Prescription Use : Yes

Device Count : 1

Pocket EEG Device, EEG Recording Viewer Software - 00851420007045 Catalog Number :

Device Class : 2

Duns Number: 079897397

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

Pocket EEG Device - 00851420007052 Catalog Number :

Device Class : 2

Duns Number: 079897397

Premarket Exempt : No

Product Code : OMB, GWQ, OMC

Prescription Use : Yes

Device Count : 1

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