21 C.F.R. § 880.2420
Electronic monitor for gravity flow infusion systems.
Cite as 21 C.F.R. § 880.2420 (2026)
(a)
Identification.
An electronic monitor for gravity flow infusion systems is a device used to monitor the amount of fluid being infused into a patient. The device consists of an electronic transducer and equipment for signal amplification, conditioning, and display.
(b)
Classification.
Class II (performance standards).