FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00

Transducer, Pressure, Catheter Tip

FIBEROPTIC SENSOR TECHNLOGIES, INC.

The following data is part of a premarket notification filed by Fiberoptic Sensor Technlogies, Inc. with the FDA for Fst Disposable Fiber Optic Transducer #0100-00.

Pre-market Notification Details

Device IDK864000
510k NumberK864000
Device Name:FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00
ClassificationTransducer, Pressure, Catheter Tip
Applicant FIBEROPTIC SENSOR TECHNLOGIES, INC. 1158 SOUTH MAIN ST. Plymouth,  MI  48170
ContactStephen Shulman
CorrespondentStephen Shulman
FIBEROPTIC SENSOR TECHNLOGIES, INC. 1158 SOUTH MAIN ST. Plymouth,  MI  48170
Product CodeDXO  
CFR Regulation Number870.2870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-10-14
Decision Date1987-01-16

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