FDA.reportPublic FDA data

EnsoSleep

Primary DI
00864458000407
Brand
EnsoSleep
Company
Ensodata, Inc.
Model
01.1
Device description
Automated sleep scoring software.
Published
2017-07-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K162627000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162627000EnsoSleepEnsodata, Inc.2017-03-31OLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864458000407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864458000407008644580004078644580004070864458000407

GMDN Terms#

Term, Definition table
TermDefinition
Sleep disorder interpretive softwareAn interpretive software program intended to collect and analyse patient physiological data during sleep and publish reports to assist a healthcare professional in the diagnosis of sleep disorders (e.g., insomnia, snoring, sleep apnoea) or to help evaluate treatment (e.g., positive airway pressure). It may be used as part of a complete polysomnography study using a wide range of data (e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement), or as part of a home-based study using a more limited data set [e.g., photoplethysmography (PPG) and motion tracking].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6085094704brock@ensodata.io

Regulatory Flags#

DUNS number
080743964
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864458000469EnsoSleep PPG82025-04-14
00864458000476EnsoSleep82025-04-14
00864458000452Celeste+82025-04-07
00864458000445EnsoSleep PPG7.02024-02-22
00864458000414EnsoSleep7.02024-02-23
00864458000421EnsoTherapy6.02023-11-20

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
00850015266706Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLZ2023-10-23
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