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 G - Miscellaneous / § 868.6400 Calibration gas.
§ 868.6400 Calibration gas.
(a) Identification. A calibration gas is a device consisting of a container of gas of known concentration intended to calibrate medical gas concentration measurement devices.
(b) Classification. Class I (general 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.