Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Mespere Lifesciences, Inc.. It received FDA 510(k) clearance on 2018-12-26 under 510(k) 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. The listed applicant is Mespere Lifesciences, Inc.. The 510(k) number is K182242.

When did VO200 – NeurOs Cerebral Oximetry System receive FDA 510(k) clearance?

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

Who is the listed applicant for VO200 – NeurOs Cerebral Oximetry System?

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

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing Mespere Lifesciences, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131085CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000

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.

↑