← Product Code [DPZ](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ) · K010718

# FLEXI-SITE SP02 EAR SENSOR (K010718)

_Epic Medical Equipment Services, Inc. · DPZ · Mar 23, 2001 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ/K010718

## Device Facts

- **Applicant:** Epic Medical Equipment Services, Inc.
- **Product Code:** [DPZ](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ.md)
- **Decision Date:** Mar 23, 2001
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 870.2710
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ/K010718](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ/K010718)

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