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510(k) K233618

Oxevision Sleep Device by Oxehealth Limited — Product Code LEL

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

Other clearances by Oxehealth Limited

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  • K220899 — Oxehealth Vital Signs (April 29, 2022)
  • K211906 — Vital Signs (July 20, 2021)
  • DEN200019 — Oxehealth Vital Signs (March 26, 2021)

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  • K233987 — VERABAND™ (June 17, 2024)
  • K231532 — ActiGraph LEAP activity monitor (ActiGraph LEAP) (June 23, 2023)
  • K181077 — ActiGraph CentrePoint Insight Watch (May 24, 2018)
  • K151784 — ActTrust (May 25, 2016)
  • K132764 — MOTION WATCH AND PRO-DIARY (January 21, 2014)
  • K111514 — SBV2, MULTICHARGER MODEL MC10V2 (December 16, 2011)
  • K040986 — CADWELL LIMB MOVEMENT MODULE (July 1, 2004)