FDA 510(k) · Oxehealth
K233618: Oxevision Sleep Device (Oxehealth Limited)
Oxehealth Limited received FDA 510(k) K233618 for Oxevision Sleep Device, with a decision date of Apr 3, 2024 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K233618 |
|---|---|
| Pathway | 510(k) |
| Applicant | Oxehealth Limited |
| Device name | Oxevision Sleep Device |
| Product code | LEL: Device, Sleep Assessment |
| Regulation (21 CFR) | 882.5050 |
| Device class | Class 2 |
| Date received | Nov 13, 2023 |
| Decision date | Apr 3, 2024 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Oxevision Sleep Device is an activity monitor designed and intended for documenting physical movements associated with applications in physiological monitoring. The device's intended use is to analyze subject activity, movement and physiological sign data associated with movement during sleep and to extract information about certain sleep parameters from these movements and physiological sign data. The device provides a timeline of periods when a bed space is occupied, and periods when a subject is asleep when the bed space is occupied. The Oxevision Sleep Device is software assessing video footage from a fixed-installation device for use within single occupancy bed spaces within hospitals, general care and secured environments. The Oxevision Sleep Device is indicated for use on subjects 18 years of age or older.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K111514 SBV2, MULTICHARGER MODEL MC10V2 (Sleep Performance (dba Fatigue Science))
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code LEL is "Device, Sleep Assessment", class 2, 21 CFR 882.5050.
Our labels for filtering: claim Sleep, sensor Other. These are heuristics, not FDA fields.