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

Reduced- Montage Standard Electroencephalograph (OMC) (9) Full-Montage Standard Electroencephalograph (GWQ) (8) Standard Polysomnograph With Electroencephalograph (OLV) (2) Ventilatory Effort Recorder (MNR) (1)

Premarket Exempt

Clear

X-Series - 00851113007734 Catalog Number :

Device Description : X24 Stat Device Kit - TRL

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

Sleep Profiler - 00851113007741 Catalog Number :

Device Description : Sleep Profiler System Kit - TRL

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OLV, OMC

Prescription Use : Yes

Device Count : 1

PoSAS - 00851113007758 Catalog Number :

Device Description : PoSAS Desktop Software

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

X-Series - 00851113007796 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 - 00851113007802 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 - 00851113007819 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 - 00851113007826 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, X8 - 00851113007833 Catalog Number :

Device Description : Bluetooth Dongle - PAN 1026

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OLV, OMC, GWQ

Prescription Use : Yes

Device Count : 1

X-Series - 00851113007840 Catalog Number :

Device Description : X24 Stat Device kit - Dongle (PAN 1026)

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : GWQ, OMC

Prescription Use : Yes

Device Count : 1

X-Series - 00851113007857 Catalog Number :

Device Description : X10 Stat Device Kit (PAN 1026)

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : GWQ, OMC

Prescription Use : Yes

Device Count : 1

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