21 C.F.R. § 868.2300 Bourdon gauge flowmeter.
Title 21 - Food and Drugs
(a) Identification. A bourdon gauge flowmeter is a device intended for medical purposes that is used in conjunction with respiratory equipment to sense gas pressure. The device is calibrated to indicate gas flow rate when the outflow is open to the atmosphere. (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 38794, July 25, 2001]
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart C—Monitoring Devices
§ 868.2300 Bourdon gauge flowmeter.
