← Product Code [DRY](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY) · K854357

# GEM-6, WITH COMPONENTS (K854357)

_Diamond Electro-Tech, Inc. · DRY · Jan 8, 1986 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K854357

## Device Facts

- **Applicant:** Diamond Electro-Tech, Inc.
- **Product Code:** [DRY](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY.md)
- **Decision Date:** Jan 8, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4330
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure 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/DRY/K854357](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DRY/K854357)

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