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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR868.6400]
See Related Information on Calibration gas. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 868 -- ANESTHESIOLOGY DEVICES

Subpart G--Miscellaneous

Sec. 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]

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