← Product Code [EXY](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY) · K945495

# 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION (K945495)

_Fiberoptic Sensor Technlogies, Inc. · EXY · Feb 9, 1995 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K945495

## Device Facts

- **Applicant:** Fiberoptic Sensor Technlogies, Inc.
- **Product Code:** [EXY](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY.md)
- **Decision Date:** Feb 9, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1800
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K945495](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K945495)

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