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FDA 510(k)

Oxehealth Vital Signs

K-Number: K220899 · 2022-04-29

ApplicantOxehealth Limited
Decision Date2022-04-29
Product CodeQME
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Oxehealth Vital Signs is a medical device manufactured by Oxehealth Limited. It received FDA 510(k) clearance on 2022-04-29 under approval number K220899. The device is classified under product code QME. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oxehealth Vital Signs?

Oxehealth Vital Signs is a medical device that received FDA 510(k) clearance on 2022-04-29. It is manufactured by Oxehealth Limited. The 510(k) number is K220899.

When was Oxehealth Vital Signs approved by the FDA?

Oxehealth Vital Signs received FDA 510(k) clearance on 2022-04-29, under approval number K220899.

What company makes Oxehealth Vital Signs?

Oxehealth Vital Signs is manufactured by Oxehealth Limited.

What is the FDA product code for Oxehealth Vital Signs?

The FDA product code for Oxehealth Vital Signs is QME.

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 40085833 The Measurement of Vital Signs in Pediatric Patients by Lifelight Software in Comparison to the Standard of Care: Protocol for the VISION-Junior Observational Study. JMIR research protocols (2025)

Other Devices by Oxehealth Limited

K211906Vital Signs DEN200019Oxehealth Vital Signs K233618Oxevision Sleep Device K243687Vital Signs K251200Vital Signs

Related Devices (Code: QME)

K211906Vital SignsOxehealth Limited DEN200019Oxehealth Vital SignsOxehealth Limited K223622FaceHeart Vitals Software Development Kit (FH vitals SDK)Faceheart Corp. K240890PanopticAI Vital SignsPanopticAI technologies Limited K241633Informed Vital Core Application (IVC App)Mindset Medical, Inc. K232804FibriCheckQompium NV

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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