21 CFR 868.2450 — Monitor, Lung Water Measurement
Anesthesiology (AN) · Part 868 Subpart C—Monitoring Devices · § 868.2450
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JEZ | Monitor, Lung Water Measurement | 3 | 1 |
