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FDA 510(k)

VO200 – NeurOs Cerebral Oximetry System

K-Number: K182242 · 2018-12-26

ApplicantMespere Lifesciences, Inc.
Decision Date2018-12-26
Product CodeQEM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VO200 – NeurOs Cerebral Oximetry System is a medical device manufactured by Mespere Lifesciences, Inc.. It received FDA 510(k) clearance on 2018-12-26 under approval number K182242. The device is classified under product code QEM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VO200 – NeurOs Cerebral Oximetry System?

VO200 – NeurOs Cerebral Oximetry System is a medical device that received FDA 510(k) clearance on 2018-12-26. It is manufactured by Mespere Lifesciences, Inc.. The 510(k) number is K182242.

When was VO200 – NeurOs Cerebral Oximetry System approved by the FDA?

VO200 – NeurOs Cerebral Oximetry System received FDA 510(k) clearance on 2018-12-26, under approval number K182242.

What company makes VO200 – NeurOs Cerebral Oximetry System?

VO200 – NeurOs Cerebral Oximetry System is manufactured by Mespere Lifesciences, Inc..

What is the FDA product code for VO200 – NeurOs Cerebral Oximetry System?

The FDA product code for VO200 – NeurOs Cerebral Oximetry System is QEM.

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Related PubMed Literature

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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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