510(k) K233618
K233618 is an FDA 510(k) premarket notification submitted by Oxehealth Limited for the device "Oxevision Sleep Device". The FDA issued a decision of Substantially Equivalent on April 3, 2024. The device falls under product code LEL (Device, Sleep Assessment), a Class II device regulated under 21 CFR 882.5050. Oxehealth Limited has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 2024
- Date Received
- November 13, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Sleep Assessment
- Device Class
- Class II
- Regulation Number
- 882.5050
- Review Panel
- NE
- Submission Type