ADVANCED BRAIN MONITORING, INC.

Address:2237 FARADAY AVE STE 100,CARLSBAD,CA,92008,US

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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

Device, Anti-Snoring (LRK) (5) Automatic Event Detection Software For Polysomnograph With Electroencephalograph (OLZ) (2) Reduced- Montage Standard Electroencephalograph (OMC) (2) Standard Polysomnograph With Electroencephalograph (OLV) (2) Electrode, Electrocardiograph (DRX) (1)

Premarket Exempt

Clear

Sleep Profiler - 00850015266539 Catalog Number :

Device Description : Sleep Profiler LE Device Kit German

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, OLV

Prescription Use : Yes

Device Count : 1

Sleep Profiler PSG2 - 00850015266546 Catalog Number :

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

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OMC, OLV

Prescription Use : Yes

Device Count : 1

Sleep Profiler - 00851113007000 Catalog Number :

Device Description : Adult General Purpose Electrodes

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Sleep Profiler - 00851113007017 Catalog Number :

Device Description : Sleep Profiler Desktop Software

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OLZ

Prescription Use : Yes

Device Count : 1

Sleep Profiler - 00851113007024 Catalog Number :

Device Description : Sleep Profiler Portal Software

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : OLZ

Prescription Use : Yes

Device Count : 1

Apnea Guard - 00851113007048 Catalog Number :

Device Description : Apnea Guard Device Low

Device Class :

Duns Number: 969842715

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Apnea Guard - 00851113007055 Catalog Number :

Device Description : Apnea Guard Device Medium

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Apnea Guard - 00851113007062 Catalog Number :

Device Description : Apnea Guard Device High

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Apnea Guard - 00851113007079 Catalog Number :

Device Description : Apnea Guard Combo Kit 1L3M1H

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Apnea Guard - 00851113007086 Catalog Number :

Device Description : Apnea Guard Combo Kit 2L2M1H

Device Class : 2

Duns Number: 969842715

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

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