FST FIBEROPTIC PRESSURE CONVERTER

Device, Cystometric, Hydraulic

FIBEROPTIC SENSOR TECHNLOGIES, INC.

The following data is part of a premarket notification filed by Fiberoptic Sensor Technlogies, Inc. with the FDA for Fst Fiberoptic Pressure Converter.

Pre-market Notification Details

Device IDK945753
510k NumberK945753
Device Name:FST FIBEROPTIC PRESSURE CONVERTER
ClassificationDevice, Cystometric, Hydraulic
Applicant FIBEROPTIC SENSOR TECHNLOGIES, INC. 501 AVIS DR. Ann Arbor,  MI  48108
ContactGary C Simpson
CorrespondentGary C Simpson
FIBEROPTIC SENSOR TECHNLOGIES, INC. 501 AVIS DR. Ann Arbor,  MI  48108
Product CodeFEN  
CFR Regulation Number876.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-23
Decision Date1995-05-11

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