21 C.F.R. § 868.1870

Current through October 31, 2024
Section 868.1870 - Gas volume calibrator
(a)Identification. A gas volume calibrator is a device that is intended for medical purposes and that is used to calibrate the output of gas volume measurement instruments by delivering a known gas volume.
(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 .

21 C.F.R. §868.1870

47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38793 , July 25, 2001