Mays & Asscoiates

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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) Standard Polysomnograph With Electroencephalograph (OLV) (2)

Premarket Exempt

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OmniPro System - B62536083000 Catalog Number : 360-8300

Device Description : The OmniAmp EEG Module is an amplifier system for use in electroencephalogram (E The OmniAmp EEG Module is an amplifier system for use in electroencephalogram (EEG) studies in a hospital or diagnosticcenter.

Device Class : 2

Duns Number: 101772069

Premarket Exempt : No

Product Code : GWQ

Prescription Use : No

Device Count : 1

OmniPro System - B62536084000 Catalog Number : 360-8400

Device Description : The OmniAmp is an amplifier system for use in polysomnogram (PSG) studies in a h The OmniAmp is an amplifier system for use in polysomnogram (PSG) studies in a hospital or diagnostic center.

Device Class : 2

Duns Number: 101772069

Premarket Exempt : No

Product Code : OLV

Prescription Use : No

Device Count : 1

OmniPro System - B62536084100 Catalog Number : 360-8410

Device Description : The OmniAmp Interface Module is an amplifier interface module used in polysomnog The OmniAmp Interface Module is an amplifier interface module used in polysomnogram (PSG) and electroencephalogram (EEG) studies in a hospital or diagnostic center

Device Class : 2

Duns Number: 101772069

Premarket Exempt : No

Product Code : GWQ, OLV

Prescription Use : No

Device Count : 1

OmniPro System - B62571883000 Catalog Number : 718-8300

Device Description : OmniPro EEG System used in EEG physiological data collection

Device Class : 2

Duns Number: 101772069

Premarket Exempt : No

Product Code : GWQ

Prescription Use : No

Device Count : 1

OmniPro System - B62571884000 Catalog Number : 718-8400

Device Description : OmniPro PSG System used in PSG physiological data collection

Device Class : 2

Duns Number: 101772069

Premarket Exempt : No

Product Code : GWQ

Prescription Use : No

Device Count : 1

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