21 CFR 868.2620 — Calibrator, Pressure, Gas

Anesthesiology (AN) · Part 868 Subpart C—Monitoring Devices · § 868.2620

Identification

A gas pressure calibrator is a device intended for medical purposes that is used to calibrate pressure-measuring instruments by generating a known gas pressure.

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
BXXCalibrator, Pressure, Gas110
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