Code of Federal Regulations · Section
§ 880.2420 — Electronic Monitor For Gravity Flow Infusion Systems
21 C.F.R. § 880.2420
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(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).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351