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FDA 510(k)

HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable

K-Number: K163381 · 2017-04-14

ApplicantEdwards Lifesciences, LLC
Decision Date2017-04-14
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2017-04-14 under approval number K163381. 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, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable?

HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable is a medical device that received FDA 510(k) clearance on 2017-04-14. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K163381.

When was HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable approved by the FDA?

HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable received FDA 510(k) clearance on 2017-04-14, under approval number K163381.

What company makes HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable?

HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable?

The FDA product code for HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable is DQK.

Related Clinical Trials

NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT07284511 A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar RECRUITING NCT07601828 Oxygen Delivery Index (ODIN) Study NOT_YET_RECRUITING NCT07592611 Deep Brain Stimulation for Treatment-Resistant Schizophrenia NOT_YET_RECRUITING NCT02361554 Deep Brain Stimulation in Treatment Resistant Schizophrenia TERMINATED NCT07552025 Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40406702 Toward a unified gait freeze index: a standardized benchmark for clinical and regulatory evaluations. Frontiers in neurology (2025)

Other Devices by Edwards Lifesciences, LLC

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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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