← Product Code [DPZ](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ) · K810363

# EAR OXIMETER (K810363)

_Bio-Tek Instruments, Inc. · DPZ · Feb 27, 1981 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ/K810363

## Device Facts

- **Applicant:** Bio-Tek Instruments, Inc.
- **Product Code:** [DPZ](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ.md)
- **Decision Date:** Feb 27, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **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/K810363](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPZ/K810363)

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