21 CFR 868.2450
§ 868.2450 Lung water monitor.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 868.2450, § 868.2450 Lung water monitor, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89757
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Full text
(a) 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.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP for a device is required to be filed with the Food and Drug Administration on or before July 12, 2000, for any lung water monitor that was in commercial distribution before May 28, 1976, or that has, on or before July 12, 2000, been found to be substantially equivalent to a lung water monitor that was in commercial distribution before May 28, 1976. Any other lung water monitor device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.