510(k) K945495
K945495 is an FDA 510(k) premarket notification submitted by Fiberoptic Sensor Technlogies, Inc. for the device "4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION". The FDA issued a decision of Substantially Equivalent on February 9, 1995. The device falls under product code EXY (Uroflowmeter), a Class II device regulated under 21 CFR 876.1800. Fiberoptic Sensor Technlogies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 1995
- Date Received
- November 8, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Uroflowmeter
- Device Class
- Class II
- Regulation Number
- 876.1800
- Review Panel
- GU
- Submission Type