510(k) K913113

FST CATH-UD CATHETER, MODIFICATION by Fiberoptic Sensor Technlogies, Inc. — Product Code FEN

K913113 is an FDA 510(k) premarket notification submitted by Fiberoptic Sensor Technlogies, Inc. for the device "FST CATH-UD CATHETER, MODIFICATION". The FDA issued a decision of Substantially Equivalent on Oct 9, 1991. The device falls under product code FEN (Device, Cystometric, Hydraulic), a Class II device regulated under 21 CFR 876.1620. Fiberoptic Sensor Technlogies, Inc. has at least 10 other 510(k) clearances on record.