Oxevision Sleep Device— 510(k) K233618
Substantially EquivalentOxehealth Limited
FDA 510(k) clearance K233618 for Oxevision Sleep Device, Substantially Equivalent on 2024-04-03. Applicant: Oxehealth Limited. Device class: 2.
Clearance details
- Applicant
- Oxehealth Limited
- Product code
- Code LEL
- Device class
- Class 2
- Regulation
- 21 CFR 882.5050
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oxford, GB
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