Cleared Traditional

Oxevision Sleep Device

K233618 · Oxehealth Limited · Neurology
Apr 2024
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K233618 is an FDA 510(k) clearance for the Oxevision Sleep Device, a Device, Sleep Assessment (Class II — Special Controls, product code LEL), submitted by Oxehealth Limited (Oxford, GB). The FDA issued a Cleared decision on April 3, 2024, 142 days after receiving the submission on November 13, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K233618 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2023
Decision Date April 03, 2024
Days to Decision 142 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code LEL — Device, Sleep Assessment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5050