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) (10) Full-Montage Standard Electroencephalograph (GWQ) (6) Standard Polysomnograph With Electroencephalograph (OLV) (4)

Premarket Exempt

Clear

X-Series - 00851113007864 Catalog Number :

Device Description : External Battery Custom Cable Kit X10, X24

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : GWQ, OMC

Prescription Use : Yes

Device Count : 1

X-Series - 00851113007871 Catalog Number :

Device Description : Disposable AgCl Sensors

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

X-Series - 00851113007888 Catalog Number :

Device Description : X10 Disposable Sensor Kit

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : GWQ, OMC

Prescription Use : Yes

Device Count : 1

X-Series - 00851113007895 Catalog Number :

Device Description : X24 Disposable Sensor Kit

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : GWQ, OMC

Prescription Use : Yes

Device Count : 1

X-Series - 00851113007918 Catalog Number :

Device Description : External Syncing Unit - Multi-Channel Kit (PAN 1026A)

Device Class :

Duns Number: 969842715

Premarket Exempt : No

Product Code : GWQ, OMC

Prescription Use : Yes

Device Count : 1

X-Series - 00851113007925 Catalog Number :

Device Description : X24 Stat Device Kit - ESU (PAN 1026A)

Device Class :

Duns Number: 969842715

Premarket Exempt : No

Product Code : GWQ, OMC

Prescription Use : Yes

Device Count : 1

Sleep Profiler - 00851113007956 Catalog Number :

Device Description : Sleep Profiler LE Device Kit

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, OLV

Prescription Use : Yes

Device Count : 1

Sleep Profiler PSG2 - 00851113007963 Catalog Number :

Device Description : Sleep Profiler PSG2 LE Device Kit No Belts (PM3)

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, OLV

Prescription Use : Yes

Device Count : 1

Sleep Profiler PSG2 - 00851113007970 Catalog Number :

Device Description : Sleep Profiler PSG2 LE Device kit - ezRIP

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, OLV

Prescription Use : Yes

Device Count : 1

Sleep Profiler PSG2 - 00851113007987 Catalog Number :

Device Description : Sleep Profiler PSG2 LE Device Kit - Piezo

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, OLV

Prescription Use : Yes

Device Count : 1

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