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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Oxehealth Limited. It received FDA 510(k) clearance on 2024-04-03 under 510(k) 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. The listed applicant is Oxehealth Limited. The 510(k) number is K233618.

When did Oxevision Sleep Device receive FDA 510(k) clearance?

Oxevision Sleep Device received FDA 510(k) clearance on 2024-04-03, under 510(k) number K233618.

Who is the listed applicant for Oxevision Sleep Device?

The FDA 510(k) record lists Oxehealth Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oxevision Sleep Device?

The FDA product code for Oxevision Sleep Device is LEL.

Other records listing Oxehealth Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251200Vital SignsK243687Vital SignsK220899Oxehealth Vital SignsK211906Vital Signs

Related Devices (Code: LEL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252981EmbraceMiniEmpatica S.r.l.K251574Sleep WatchAmbulatory Monitoring, Inc.K243513DCM (PW-DCM)Pneumowave, Ltd.K233987VERABAND™Arbor Medical Innovations, LLCK231532ActiGraph LEAP activity monitor (ActiGraph LEAP)Actigraph, LLCK181077ActiGraph CentrePoint Insight WatchActigraph

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.

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