[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR868.2450]

[Page 279]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 868--ANESTHESIOLOGY DEVICES--Table of Contents
 
                      Subpart C--Monitoring Devices
 
Sec. 868.2450  Lung water monitor.

    (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.

[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 65 
FR 19834, Apr. 13, 2000]