Oxevision Sleep Device
K-Number: K233618 · 2024-04-03
ApplicantOxehealth Limited
Decision Date2024-04-03
Product CodeLEL
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Oxevision Sleep Device is a medical device manufactured by Oxehealth Limited. It received FDA 510(k) clearance on 2024-04-03 under approval number K233618. The device is classified under product code LEL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Oxevision Sleep Device?
Oxevision Sleep Device is a medical device that received FDA 510(k) clearance on 2024-04-03. It is manufactured by Oxehealth Limited. The 510(k) number is K233618.
When was Oxevision Sleep Device approved by the FDA?
Oxevision Sleep Device received FDA 510(k) clearance on 2024-04-03, under approval number K233618.
What company makes Oxevision Sleep Device?
Oxevision Sleep Device is manufactured by Oxehealth Limited.
What is the FDA product code for Oxevision Sleep Device?
The FDA product code for Oxevision Sleep Device is LEL.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.