21 CFR § 880.2420 - Electronic monitor for gravity flow infusion systems.
§ 880.2420 Electronic monitor for gravity flow infusion systems.
(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).