FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Oxevision Sleep Device
K Number: K233618
·
Decision Apr 3, 2024
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
18
Applicant Total
6
Review Days
142
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Basic Information
- Device Name
- Oxevision Sleep Device
- K Number
- K233618
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oxehealth Limited
- Date Received
- November 13, 2023
- Decision Date
- April 3, 2024
- Product Code
- LEL
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LEL | Device, Sleep Assessment | FDA class 2 | Neurology |
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Other Clearances by Oxehealth Limited
| K Number | Device Name | ||
|---|---|---|---|
| K251200 | Vital Signs | Feb 2, 2026 | Substantially Equivalent |
| K243687 | Vital Signs | Aug 27, 2025 | Substantially Equivalent |
| K220899 | Oxehealth Vital Signs | Apr 29, 2022 | Substantially Equivalent |
| K211906 | Vital Signs | Jul 20, 2021 | Substantially Equivalent |
| DEN200019 | Oxehealth Vital Signs | Mar 26, 2021 | Unknown |