ADVANCED BRAIN MONITORING, INC.

Address:2237 FARADAY AVE STE 100,CARLSBAD,CA,92008,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) (10) Reduced- Montage Standard Electroencephalograph (OMC) (10)

Premarket Exempt

Clear

X-Series - 00851113007635 Catalog Number :

Device Description : X-Small Strip Kit

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

X-Series - 00851113007642 Catalog Number :

Device Description : Small Strip Kit

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

X-Series - 00851113007659 Catalog Number :

Device Description : Medium Strip Kit

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

X-Series - 00851113007666 Catalog Number :

Device Description : 10-20 X-Small Strip Kit

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

X-Series - 00851113007673 Catalog Number :

Device Description : 10-20 Small Strip Kit

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

X-Series - 00851113007680 Catalog Number :

Device Description : 10-20 Medium Strip Kit

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

X-Series - 00851113007697 Catalog Number :

Device Description : X10 Disposable Sensor Kit

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

X-Series - 00851113007703 Catalog Number :

Device Description : X10 Stat Device Kit

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

X-Series - 00851113007710 Catalog Number :

Device Description : X24 Stat Device Kit - ESU

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

X-Series - 00851113007727 Catalog Number :

Device Description : X24 Stat Device kit - Dongle

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

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