FDA 510(k)

Vital Signs

K-Number: K211906 · 2021-07-20

Decision Date2021-07-20

Product CodeQME

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Vital Signs is the device name listed in this FDA 510(k) record. The listed applicant is Oxehealth Limited. It received FDA 510(k) clearance on 2021-07-20 under 510(k) 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. The listed applicant is Oxehealth Limited. The 510(k) number is K211906.

When did Vital Signs receive FDA 510(k) clearance?

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

Who is the listed applicant for Vital Signs?

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 Vital Signs?

The FDA product code for Vital Signs is QME.

Related Clinical Trials

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.

NCT02804022Vital-signs-integrated Patient-assisted Intravenous Opioid AnalgesiaACTIVE_NOT_RECRUITING NCT02907255Vital Sign Monitoring With Continuous Pulse Oximetry and Wireless Clinician Notification After SurgeryCOMPLETED NCT03750318Validation Study on RENEW's Aingeal at KK Women's and Children's HospitalACTIVE_NOT_RECRUITING NCT04011163Vital Signs-Integrated Patient-Assisted Intravenous Opioid Analgesia for Post Surgical PainACTIVE_NOT_RECRUITING NCT04723654Evaluating Wearable Smart Sensors for Continuous Measurement of Vital Signs in ICU PatientsRECRUITING NCT05181111Continuous Monitoring of Patients in and After the Acute Admission Ward to Optimize Clinical PathwaysCOMPLETED

Other records listing Oxehealth Limited as applicant

K251200Vital Signs K243687Vital Signs K233618Oxevision Sleep Device K220899Oxehealth Vital Signs

Related Devices (Code: QME)

K254169SmartSpectra Vital Signs Monitor 1.0Presage Security, Inc. d/b/a Presage Technologies, Inc.K253650Anura Mobile Core SDK (M1)Nuralogix Corporation K260066PanopticAI Vital Signs (1.6.1-22)PanopticAI Technologies Limited K251200Vital SignsOxehealth Limited K243687Vital SignsOxehealth Limited K250078Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)Mindset Medical, Inc.

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.