Oxevision Sleep Device
FDA 510(k) K233618 · Oxehealth Limited
510(k) numberK233618
Submission
- Device name
- Oxevision Sleep Device
- Applicant
- Oxehealth Limited
Oxford, GB - Received
- November 13, 2023
- Decision date
- April 3, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K151784 | ActTrustLEL · Traditional | Condor Instruments Ltda. - Epp | 05/25/2016SE |
| K132764 | Motion Watch and Pro-DiaryLEL · Traditional | Camntech, Ltd. | 01/21/2014SE |
| K111514 | SBV2, Multicharger Model MC10V2LEL · Traditional | Sleep Performance D.B.A. Fatigue Science | 12/16/2011SE |
| K040986 | Cadwell Limb Movement ModuleLEL · Traditional | Cadwell Laboratories, Inc. | 07/01/2004SE |
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Questions and answers
When was Oxevision Sleep Device cleared by the FDA?
Oxevision Sleep Device (K233618) received a 510(k) decision of Substantially Equivalent on April 3, 2024, 142 days after the submission was received.
What is the product code of K233618?
The FDA product code is LEL – Device, Sleep Assessment, a Class II (moderate risk) device regulated under 21 CFR 882.5050.