(a) Identification. A pneumotachometer is a device intended for medical purposes that is used to determine gas flow by measuring the pressure differential across a known resistance. The device may use a set of capillaries or a metal screen for the resistive element.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.