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FDA 510(k)

Vital Signs

K-Number: K211906 · 2021-07-20

ApplicantOxehealth Limited
Decision Date2021-07-20
Product CodeQME
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vital Signs is a medical device manufactured by Oxehealth Limited. It received FDA 510(k) clearance on 2021-07-20 under approval number K211906. 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 Vital Signs?

Vital Signs is a medical device that received FDA 510(k) clearance on 2021-07-20. It is manufactured by Oxehealth Limited. The 510(k) number is K211906.

When was Vital Signs approved by the FDA?

Vital Signs received FDA 510(k) clearance on 2021-07-20, under approval number K211906.

What company makes Vital Signs?

Vital Signs is manufactured by Oxehealth Limited.

What is the FDA product code for Vital Signs?

The FDA product code for 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)

Other Devices by Oxehealth Limited

DEN200019Oxehealth Vital Signs K220899Oxehealth Vital Signs K233618Oxevision Sleep Device K243687Vital Signs K251200Vital Signs

Related Devices (Code: QME)

DEN200019Oxehealth Vital SignsOxehealth Limited K220899Oxehealth 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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