FDA.reportPublic FDA data

Sleep Profiler

Primary DI
00850015266706
Brand
Sleep Profiler
Company
ADVANCED BRAIN MONITORING, INC.
Model
SP42-5402
Device description
Sleep Profiler RTA Software
Published
2023-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLZAutomatic Event Detection Software For Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120450000
K130007000
K153412000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120450000SLEEP PROFILERAdvanced Brain Monitoring, Inc.2012-09-19OLZ
K130007000SLEEP PROFILERAdvanced Brain Monitoring, Inc.2013-04-17OLZ
K153412000Sleep ProfilerAdvanced Brain Monitoring, Inc.2016-03-14OLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850015266706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015266706008500152667068500152667060850015266706

GMDN Terms#

Term, Definition table
TermDefinition
Polysomnography analyserA mains electricity (AC-powered) device designed to record and interpret a variety of physiologic functions during sleep to evaluate sleep/sleep-related disorders (e.g., insomnia, hypersomnia, apnoea). It typically performs electroencephalography, electrocardiography, electro-oculography, electromyography, and respiration, temperature, and pulse oximetry readings. It may also provide audiovisual information about the sleeping patient for behavioral analysis and other measurements (e.g., gastric reflux, bedwetting). The device includes electrodes, measuring instruments, samplers, filters, amplifiers, and appropriate software for processing data and providing patient diagnoses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
969842715
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850063034289Night ShiftNS27-4102.XXL2025-07-21
00850015266492Night ShiftNS27-41022022-03-29
00850015266508Night ShiftNS27-4102.XXL2022-03-29
00850063034265Night ShiftNS27-1010.LE2025-05-22
00851113007123Apnea GuardAG25-4107.202016-09-23
00850063034135X-SeriesXS30-1015.LE2025-01-29
00850063034166X-SeriesXS30-1001.LE2025-01-29
00850063034180X-SeriesXS30-1007.LE2025-01-29
00850063034128Sleep ProfilerSP29-1015.LE2025-01-28
00850063034142Sleep Profiler PSG2SP29-1002.LE2025-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008953117NEATBrain Electrophysiology Laboratory Company, LLCOLZ2026-05-12
00850049266055WavebandBeacon Biosignals, Inc.OLZ2026-04-17
00850049266062WavebandBeacon Biosignals, Inc.OLZ2026-04-17
B566847020ZmachineGeneral SleepOLZ2026-04-16
00606959055735Sleepware G3 Respironics, Inc.OLZ2026-01-22
00817111021332PolysmithNeurotronics, LLCOLZ2025-09-23
15694311112099DeepRESPNox Medical ehf.OLZ2025-06-06
00864458000476EnsoSleepEnsodata, Inc.OLZ2025-04-14
00817111021264Live View Panel Pro Version 2.0Neurotronics, LLCOLZ2024-05-09
00864458000414EnsoSleepEnsodata, Inc.OLZ2024-02-23
00817111021257Polysmith Version 12.2Neurotronics, LLCOLZ2022-12-28
B600700014Cerebra Sleep SystemCerebra Medical LtdOLZ2022-07-13
15694311111665Noxturnal US APPNox Medical ehf.OLZ2021-10-18
15694311111610Nox A1® EEG 5 Lead Gold Electrode CableNox Medical ehf.OLZ2021-09-07
15694311111627Nox A1® EEG Head Cable Nox Medical ehf.OLZ2021-09-07
15694311111566Nox A1s RecorderNox Medical ehf.OLZ2021-07-10
15694311111580Nox A1s SystemNox Medical ehf.OLZ2021-07-10
15694311111597Nox C1s KitNox Medical ehf.OLZ2021-07-10
15694311110682Nox A1 Starter Sensor Kit, AdultNox Medical ehf.OLZ2021-02-03
15694311110699Nox A1 Starter Sensor Kit, PediatricNox Medical ehf.OLZ2021-02-03
15694311111498Nox C1 Access PointNox Medical ehf.OLZ2021-02-03
15694311111504Nox C1 KitNox Medical ehf.OLZ2021-02-03
00627987257502Esprit NovaSignalitica IncOLZ2020-12-06
15694311110095Nox A1 Carry CaseNox Medical ehf.OLZ2020-04-27
15694311110453Nox A1 EEG 5 Lead Gold Electrode CableNox Medical ehf.OLZ2020-04-27
15694311110521Nox A1 EEG Head CableNox Medical ehf.OLZ2020-04-27
00817111021172Polysmith Version 12.0Neurotronics, LLCOLZ2020-04-01
15694311110019Noxturnal APPNox Medical ehf.OLZ2020-02-24
15694311110590Nox C1 Access PointNox Medical ehf.OLZ2020-02-24
15694311110903Nox A1 RecorderNox Medical ehf.OLZ2020-02-24