4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION
Device Facts
| Record ID | K945495 |
|---|---|
| Device Name | 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION |
| Applicant | Fiberoptic Sensor Technlogies, Inc. |
| Product Code | EXY · Gastroenterology, Urology |
| Decision Date | Feb 9, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1800 |
| Device Class | Class 2 |
Regulatory Classification
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.
