FDA.reportPublic FDA data

Oxevision Sleep system

Primary DI
50607514500023
Brand
Oxevision Sleep system
Company
OXEHEALTH LIMITED
Model
2
Device description
Sleep disorder interpretive software, professional-only
Published
2025-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LELDevice, Sleep Assessment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LELDevice, Sleep AssessmentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233618000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233618000Oxevision Sleep DeviceOxehealth Limited2024-04-03LEL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50607514500023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5060751450002350607514500023

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

Contacts#

Phone, Email table
PhoneEmail
+1 (888) 871-8108john.kemeny@oxehealth.com

Regulatory Flags#

DUNS number
218519521
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50607514500009Vital Signs22025-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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