← Product Code [DTY](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTY) · K954501

# BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM (K954501)

_Medtronic Bio-Medicus, Inc. · DTY · Jan 16, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTY/K954501

## Device Facts

- **Applicant:** Medtronic Bio-Medicus, Inc.
- **Product Code:** [DTY](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTY.md)
- **Decision Date:** Jan 16, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4410
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTY/K954501](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTY/K954501)

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