Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2700](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2700) → QEM — Cerebral Oximeter

# QEM · Cerebral Oximeter

_Cardiovascular · 21 CFR 870.2700 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QEM

## Overview

- **Product Code:** QEM
- **Device Name:** Cerebral Oximeter
- **Regulation:** [21 CFR 870.2700](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2700)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K182242](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QEM/K182242.md) | VO200 – NeurOs Cerebral Oximetry System | Mespere Lifesciences, Inc. | Dec 26, 2018 | SESE |

## Top Applicants

- Mespere Lifesciences, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QEM](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QEM)

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