21 CFR 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.

[ 47 FR 31142, July 16, 1982, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code

Title 21 published on 2015-12-03

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 868 after this date.

  • 2016-02-12; vol. 81 # 29 - Friday, February 12, 2016
    1. 81 FR 7446 - Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective February 12, 2016.
      21 CFR Parts 868 and 870