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FDA 510(k)

HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module

K-Number: K190205 · 2019-08-29

ApplicantEdwards Lifesciences, LLC
Decision Date2019-08-29
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2019-08-29 under approval number K190205. 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 Tissue Oximetry Module?

HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module is a medical device that received FDA 510(k) clearance on 2019-08-29. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K190205.

When was HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module approved by the FDA?

HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module received FDA 510(k) clearance on 2019-08-29, under approval number K190205.

What company makes HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module?

HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module?

The FDA product code for HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module is DQK.

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Related PubMed Literature

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