21 CFR 868.6400 — Gas, Calibration (Specified Concentration)

Anesthesiology (AN) · Part 868 Subpart G—Miscellaneous · § 868.6400

Identification

A calibration gas is a device consisting of a container of gas of known concentration intended to calibrate medical gas concentration measurement devices.

Classification Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
BXKGas, Calibration (Specified Concentration)132
Innolitics

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