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FDA 510(k)

HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform

K-Number: K211465 · 2021-07-08

ApplicantEdwards Lfesciences
Decision Date2021-07-08
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform is a medical device manufactured by Edwards Lfesciences. It received FDA 510(k) clearance on 2021-07-08 under approval number K211465. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform?

HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform is a medical device that received FDA 510(k) clearance on 2021-07-08. It is manufactured by Edwards Lfesciences. The 510(k) number is K211465.

When was HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform approved by the FDA?

HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform received FDA 510(k) clearance on 2021-07-08, under approval number K211465.

What company makes HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform?

HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform is manufactured by Edwards Lfesciences.

What is the FDA product code for HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform?

The FDA product code for HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform is DQK.

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT05418790 A Pilot Study to Evaluate Alternative Viral Load Tests During Start of Antiretroviral Therapy WITHDRAWN NCT06682013 Virtual Agent Feasibility in Oncology Patients (NTT Data) WITHDRAWN NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07124247 Implementation of the MOX Activity Monitor in Hospitalized Geriatric Rehabilitation COMPLETED

Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41105489 Medical device shelf-life and recalls: navigating healthcare challenges. Expert review of medical devices (2025) PMID: 40947420 Software as Medical Devices: requirements and regulatory landscape in the United States. Expert review of medical devices (2025) PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025)

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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.

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