Devices · Oxehealth Limited

Oxevision Sleep Device

Oxehealth Limited is listed for Oxevision Sleep Device (K233618). The FDA list gives April 3, 2024 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is LEL. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233618

Official FDA database record

Date of final decision

April 3, 2024

Company on the FDA list

Oxehealth Limited

Lead panel

Neurology

Primary product code

LEL

openFDA device name for the code

Device, Sleep Assessment

Device class

2

Regulation number

882.5050

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary