FDA 510(k)

HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module

K-Number: K190205 · 2019-08-29

Decision Date2019-08-29

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2019-08-29 under 510(k) 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. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K190205.

When did HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module receive FDA 510(k) clearance?

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

Who is the listed applicant for HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

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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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.