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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Sleep Assessment
510(k) Number K233618
Device Name Oxevision Sleep Device
Applicant
Oxehealth Limited
Magdalen Centre North
Oxford Science Park
Oxford,  GB OX4 4GA
Applicant Contact Joao Jorge
Correspondent
Oxehealth Limited
Magdalen Centre North
Oxford Science Park
Oxford,  GB OX4 4GA
Correspondent Contact Joao Jorge
Regulation Number882.5050
Classification Product Code
LEL  
Date Received11/13/2023
Decision Date 04/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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