FDA.reportPublic FDA data

Sleep Profiler

Primary DI
00851113007215
Brand
Sleep Profiler
Company
ADVANCED BRAIN MONITORING, INC.
Model
SP40-4101
Device description
Sleep Profiler Headband Kit
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLVStandard Polysomnograph With Electroencephalograph
OMCReduced- Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLVStandard Polysomnograph With ElectroencephalographNeurology2
OMCReduced- Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120447000
K130013000
K152040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120447000X4Advanced Brain Monitoring, Inc.2012-06-20OMC
K130013000X4 SYSTEMAdvanced Brain Monitoring, Inc.2013-01-31OMC
K152040000X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)Advanced Brain Monitoring, Inc.2015-10-30OMC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851113007212PackageGS125In Commercial Distribution
20851113007219PackageGS150In Commercial Distribution
00851113007215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085111300721210851113007212
2085111300721920851113007219
00851113007215008511130072158511130072150851113007215

GMDN Terms#

Term, Definition table
TermDefinition
Electrode/transducer strap, reusableA strip of material (e.g., fabric) intended to be used to hold electrodes and/or transducers (e.g., foetal monitoring transducers) in place on the body surface; it typically has fasteners (e.g., Velcro, buckle). This is a reusable device.

Regulatory Flags#

DUNS number
969842715
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850063034401Sleep Profiler PSG2SP29-1017.LE2026-09-25
00850063034418Sleep Profiler PSG2SP29-1018.LE2026-09-25
00850063034425Sleep ProfilerSP29-1020.LE2026-09-25
00850063034432Sleep ProfilerSP29-1020.LE(ITA)2026-09-25
00850063034449Sleep ProfilerSP29-1021.LE2026-09-25
00850063034456Sleep ProfilerSP29-1022.LE2026-09-25
00850063034470Sleep ProfilerSP29-1025.LE2026-09-25
00850063034487Sleep ProfilerSP29-1026.LE2026-09-25
00850063034494Sleep ProfilerSP29-1027.LE2026-09-25
00850063034524Sleep ProfilerSP29-1020.LE(GER)2026-09-25
00850063034364Sleep ProfilerSP40-1001.LE(GRE)2025-12-22
00850063034296Night ShiftNS27-1010.LE2025-12-08
00850063034319Night ShiftNS27-1005.LE(FIN)2025-12-08
00850063034326Night ShiftNS27-1005.LE(NOR)2025-12-08
00850063034333Night ShiftNS27-1005.LE(SWE)2025-12-08
00850063034357Night ShiftNS27-1010.LE(FRE)2025-12-08
00850063034340Night ShiftNS27-1010.LE(ENSO)2025-11-14
70850015266194Night ShiftNS27-1005.LE(ENSO)2025-10-27
00850063034302Night ShiftNS27-1005.LE(DAN)2025-08-21
00850063034272Night ShiftNS27-41022025-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063034401Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034401Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034418Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034418Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034425Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034425Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034432Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034432Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034449Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034449Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034456Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034456Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034470Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034470Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034487Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034487Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034494Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034494Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034524Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034524Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.OMC2026-09-04
08720256698296Onera STS 2Onera B.V.OLV2026-05-15
08720256698302Onera STS 2Onera B.V.OLV2026-05-15
08720256698319Onera STS 2Onera B.V.OLV2026-05-15
08720256698326Onera STS 2Onera B.V.OLV2026-05-15
08720256698333Onera STS 2Onera B.V.OLV2026-05-15
08720256698340Onera STS 2Onera B.V.OLV2026-05-15
08720256698357Onera STS 2Onera B.V.OLV2026-05-15
08720256698364Onera STS 2Onera B.V.OLV2026-05-15
08720256698371Onera STS 2Onera B.V.OLV2026-05-15