← Product Code [DQA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA) · K884822

# MODEL OX-1 OXYGEN SATURATION MODULE (K884822)

_Colin Medical Instruments Corp. · DQA · Mar 2, 1989 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K884822

## Device Facts

- **Applicant:** Colin Medical Instruments Corp.
- **Product Code:** [DQA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA.md)
- **Decision Date:** Mar 2, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2700
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K884822](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K884822)

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