← Product Code [DXL](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXL) · K760448

# SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT (K760448)

_Instrumentation Laboratory CO · DXL · Aug 27, 1976 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXL/K760448

## Device Facts

- **Applicant:** Instrumentation Laboratory CO
- **Product Code:** [DXL](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXL.md)
- **Decision Date:** Aug 27, 1976
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1660
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An indicator injector is an electrically or gas-powered device designed to inject accurately an indicator solution into the blood stream. This device may be used in conjuction with a densitometer or thermodilution device to determine cardiac output.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXL/K760448](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXL/K760448)

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