21 CFR 876.1800
§ 876.1800 Urine flow or volume measuring system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 876.1800, § 876.1800 Urine flow or volume measuring system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90285
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Full text
(a) Identification. A urine flow or volume measuring system is a device that measures directly or indirectly the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder and a transducer and electrical signal conditioning and display equipment. This generic type of device includes the electrical urinometer, mechanical urinometer, nonelectric urinometer, disposable nonelectric urine flow rate measuring device, and uroflowmeter.
(b) Classification.
(1) Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.