21 C.F.R. § 870.3640 Indirect pacemaker generator function analyzer.
Title 21 - Food and Drugs
(a) Identification. An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or pacemaker battery function by periodically monitoring an implanted pacemaker's pulse rate and pulse width. The device is noninvasive, and it detects pacemaker pulse rate and width via external electrodes in contact with the patient's skin. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart D—Cardiovascular Prosthetic Devices
§ 870.3640 Indirect pacemaker generator function analyzer.
