21 C.F.R. § 868.2340

Current through September 30, 2024
Section 868.2340 - Compensated thorpe tube flowmeter
(a)Identification. A compensated thorpe tube flowmeter is a device intended for medical purposes that is used to control and measure gas flow rate accurately. The device includes a vertically mounted tube, with the outlet of the flowmeter calibrated to a reference pressure.
(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 .

21 C.F.R. §868.2340

47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001