VO200 – NeurOs Cerebral Oximetry System

FDA 510(k) K182242 · Mespere Lifesciences, Inc.

Substantially Equivalent

510(k) numberK182242

Submission

Device name
VO200 – NeurOs Cerebral Oximetry System
Applicant
Mespere Lifesciences, Inc.
Waterloo, CA
Received
August 20, 2018
Decision date
December 26, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QEM – Cerebral Oximeter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2700
Specialty
Cardiovascular

Oximeter to measure cerebral tissue saturation

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Questions and answers

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

VO200 – NeurOs Cerebral Oximetry System (K182242) received a 510(k) decision of Substantially Equivalent on December 26, 2018, 128 days after the submission was received.

What is the product code of K182242?

The FDA product code is QEM – Cerebral Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.