21 CFR 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.
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.