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e-CFR data is current as of August 6, 2020

Title 21Chapter ISubchapter HPart 868Subpart B → §868.1870


Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart B—Diagnostic Devices


§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.

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

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