← Product Code [IYT](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYT) · K896124

# MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133 (K896124)

_Medipart Jerry Alexander · IYT · Jan 22, 1990 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYT/K896124

## Device Facts

- **Applicant:** Medipart Jerry Alexander
- **Product Code:** [IYT](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYT.md)
- **Decision Date:** Jan 22, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1390
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A radionuclide rebreathing system is a device intended to be used to contain a gaseous or volatile radionuclide or a radionuclide-labeled aerosol and permit it to be respired by the patient during nuclear medicine ventilatory tests (testing process of exchange between the lungs and the atmosphere). This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYT/K896124](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYT/K896124)

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