JEZ · Monitor, Lung Water Measurement
Anesthesiology · 21 CFR 868.2450 · Class 3
Overview
| Product Code | JEZ |
|---|---|
| Device Name | Monitor, Lung Water Measurement |
| Regulation | 21 CFR 868.2450 |
| Device Class | Class 3 |
| Review Panel | Anesthesiology |
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 | MODEL 9310 LUNG WATER COMPUTER | Edwards Lifesciences, LLC | Jul 28, 1980 | APWD |
Top Applicants
- Edwards Lifesciences, LLC — 1 clearance
