Code of Federal Regulations Title 21. Food and Drugs § 21.868.2377 Apnea monitor

(a) Identification. An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.

(b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document:  Apnea Monitors;  Guidance for Industry and FDA.”