Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 868 - ANESTHESIOLOGY DEVICES
/ Subpart C - Monitoring Devices / § 868.2550 Pneumotachometer.
§ 868.2550 Pneumotachometer.
(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.