Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart B — Diagnostic Devices](/submissions/GU/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 876.1800](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1800) → EXS — Urinometer, Electrical

# EXS · Urinometer, Electrical

_Gastroenterology, Urology · 21 CFR 876.1800 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXS

## Overview

- **Product Code:** EXS
- **Device Name:** Urinometer, Electrical
- **Regulation:** [21 CFR 876.1800](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1800)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## 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.

## Classification Rationale

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.

## Special Controls

*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.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXS](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXS)

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