FDA.reportPublic FDA data

EnsoSleep PPG

Primary DI
00864458000469
Brand
EnsoSleep PPG
Company
Ensodata, Inc.
Model
8
Device description
Sleep quality and sleep disordered breathing detection from pulse oximeters. Marketed as EnsoSleep PPG or Aurora
Published
2025-04-14
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
MNRVentilatory Effort Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231355000AuroraEnsodata2024-02-09MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864458000469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864458000469008644580004698644580004690864458000469

GMDN Terms#

Term, Definition table
TermDefinition
Sleep disorder interpretive software, professional-onlyAn interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080743964
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864458000476EnsoSleep82025-04-14
00864458000452Celeste+82025-04-07
00864458000445EnsoSleep PPG7.02024-02-22
00864458000414EnsoSleep7.02024-02-23
00864458000407EnsoSleep01.12017-07-19
00864458000421EnsoTherapy6.02023-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08885021950013TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08885021950136TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08720256698296Onera STS 2Onera B.V.MNR2026-05-15
08720256698302Onera STS 2Onera B.V.MNR2026-05-15
08720256698319Onera STS 2Onera B.V.MNR2026-05-15
08720256698326Onera STS 2Onera B.V.MNR2026-05-15
08720256698333Onera STS 2Onera B.V.MNR2026-05-15
08720256698340Onera STS 2Onera B.V.MNR2026-05-15
08720256698357Onera STS 2Onera B.V.MNR2026-05-15
08720256698364Onera STS 2Onera B.V.MNR2026-05-15
08720256698371Onera STS 2Onera B.V.MNR2026-05-15
08720256698463Onera STSOnera B.V.MNR2026-05-15
08720256698487Onera STSOnera B.V.MNR2026-05-15
08720256698494Onera STSOnera B.V.MNR2026-05-15
08720256698500Onera STSOnera B.V.MNR2026-05-15
08720256698517Onera STSOnera B.V.MNR2026-05-15
08720256698524Onera STSOnera B.V.MNR2026-05-15
08720256698531Onera STSOnera B.V.MNR2026-05-15
08885021950044TipTraQPRANAQ PTE. LTD.MNR2026-05-15
08885021950051TipTraQPRANAQ PTE. LTD.MNR2026-05-11
B566847001ZmachineGeneral SleepMNR2026-04-09
B566847002ZmachineGeneral SleepMNR2026-04-09
09342451002655Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
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09342451002754Compumedics FalconCOMPUMEDICS LIMITEDMNR2026-03-12
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09342451002822Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002860Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451007063Compumedics Somfit DCOMPUMEDICS LIMITEDMNR2026-03-12