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) (6) Full-Montage Standard Electroencephalograph (GWQ) (4) Device, Anti-Snoring (LRK) (2) Pillow,Cervical(For Mild Sleep Apnea) (MYB) (2) Standard Polysomnograph With Electroencephalograph (OLV) (2) Ventilatory Effort Recorder (MNR) (2)

Premarket Exempt

Clear

Sleep Profiler PSG2 - 00850015266201 Catalog Number :

Device Description : Effort Cable Single Channel Kit

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OLV, OMC

Prescription Use : Yes

Device Count : 1

Night Shift - 00850015266218 Catalog Number :

Device Description : Night Shift LE Device Kit - Spanish

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : MYB, MNR

Prescription Use : Yes

Device Count : 1

Sleep Profiler - 00850015266225 Catalog Number :

Device Description : Sleep Profiler Device Kit (No sensors)

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OLV, OMC

Prescription Use : Yes

Device Count : 1

Night Shift - 00850015266232 Catalog Number :

Device Description : Night Shift LE Device Kit - Traditional Chinese

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : MYB, MNR

Prescription Use : Yes

Device Count : 1

Apnea Guard - 00850015266263 Catalog Number :

Device Description : Apnea Guard Starter Kit 1L3M1H (SPA)

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Apnea Guard - 00850015266270 Catalog Number :

Device Description : Apnea Guard Starter Kit 2L2M1H (SPA)

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

X-Series - 00850015266287 Catalog Number :

Device Description : 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 - 00850015266294 Catalog Number :

Device Description : Medium 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 - 00850015266300 Catalog Number :

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

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

X-Series - 00850015266317 Catalog Number :

Device Description : Medium 10-20 Single-Use Strip Kit

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, GWQ

Prescription Use : Yes

Device Count : 1

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