Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019791389

FEI Number

3019791389

Entity Name

OXEHEALTH LTD

City/State/Country

Abingdon Oxfordshire, GB

Establishment Address

Bee House, 140 Eastern Avenue; Oxford, Abingdon Oxfordshire OX14 4SB, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Oxehealth Ltd (Owner Number: 10082091)

Owner / Operator Contact Address

Oxehealth Limited, Bee House, Eastern Avenue, Milton, Abingdon, GB-OXF OX14 4SB, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN200019

PMA Number

N/A

All Registered Proprietary Names

Oxevision Sleep System Vital Signs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LEL	Device, Sleep Assessment	Neurology	Class 2	882.5050	2024-04-11
QME	Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate	Cardiovascular	Class 2	870.2785	2021-06-15

Official Correspondent

John Kemeny

US Agent Details

john Kress Email: john.kress@liohealth.com Phone: (931) 2010844

Related Public Records

Same Entity

Oxehealth Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3012933969	EMPATICA S.r.l.	Milano, IT
3012324979	SHENZHEN FENDA TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN
3020018	CADWELL INDUSTRIES, INC.	KENNEWICK, WA, US
3013896610	Hypertec HCM LLC	Plainfield, IN, US
3033715634	HAPPY HEALTH	Austin, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019791389. Last updated year: 2026. Please use registration number 3019791389 when referencing this establishment in official correspondence.