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) (6) Reduced- Montage Standard Electroencephalograph (OMC) (6) Device, Anti-Snoring (LRK) (4)

Premarket Exempt

Clear

X-Series - 00850015266324 Catalog Number :

Device Description : Small 10-20 Single-Use Strip Kit (Qty 5)

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

X-Series - 00850015266331 Catalog Number :

Device Description : Medium 10-20 Single-Use Strip Kit (Qty 5)

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

X-Series - 00850015266348 Catalog Number :

Device Description : X24 Stat System Kit Clinical

Device Class :

Duns Number: 969842715

Premarket Exempt : No

Product Code : GWQ, OMC

Prescription Use : Yes

Device Count : 1

Apnea Guard - 00850015266362 Catalog Number :

Device Description : Apnea Guard Starter Kit 1L3M6H (V2)

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Apnea Guard - 00850015266379 Catalog Number :

Device Description : Apnea Guard Resupply Kit 5L10M20H (V2)

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Apnea Guard - 00850015266386 Catalog Number :

Device Description : Apnea Guard Starter Kit 1L2M2H (V2)

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Apnea Guard - 00850015266393 Catalog Number :

Device Description : Apnea Guard Starter Kit 1L2M2H Spanish (V2)

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

X-Series - 00850015266409 Catalog Number :

Device Description : Disposable Foam Sensors (Qty 252)

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

X-Series - 00850015266416 Catalog Number :

Device Description : X-Small 10-20 Single-Use Strip

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

X-Series - 00850015266423 Catalog Number :

Device Description : X-Small 10-20 Single-Use Strip Kit (Qty 2)

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

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