Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart C — Monitoring Devices](/submissions/AN/subpart-c%E2%80%94monitoring-devices) → [21 CFR 868.2450](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2450) → JEZ — Monitor, Lung Water Measurement

# JEZ · Monitor, Lung Water Measurement

_Anesthesiology · 21 CFR 868.2450 · Class 3_

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

## Overview

- **Product Code:** JEZ
- **Device Name:** Monitor, Lung Water Measurement
- **Regulation:** [21 CFR 868.2450](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2450)
- **Device Class:** 3
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A lung water monitor is a device used to monitor the trend of fluid volume changes in a patient's lung by measuring changes in thoracic electrical impedance (resistance to alternating current) by means of electrodes placed on the patient's chest.

## Classification Rationale

Class III (premarket approval).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P800003](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/JEZ/P800003.md) | MODEL 9310 LUNG WATER COMPUTER | Edwards Lifesciences, LLC | Jul 28, 1980 | APWD |

## Top Applicants

- Edwards Lifesciences, LLC — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
