URO-PRO 2000

Cystometric Gas (carbon-dioxide) On Hydraulic Device

FIBEROPTIC SENSOR TECHNLOGIES, INC.

The following data is part of a premarket notification filed by Fiberoptic Sensor Technlogies, Inc. with the FDA for Uro-pro 2000.

Pre-market Notification Details

Device IDK922476
510k NumberK922476
Device Name:URO-PRO 2000
ClassificationCystometric Gas (carbon-dioxide) On Hydraulic Device
Applicant FIBEROPTIC SENSOR TECHNLOGIES, INC. 501 AVIS DR. Ann Arbor,  MI  48108
ContactDouglas G Tomasko
CorrespondentDouglas G Tomasko
FIBEROPTIC SENSOR TECHNLOGIES, INC. 501 AVIS DR. Ann Arbor,  MI  48108
Product CodeFAP  
CFR Regulation Number876.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-26
Decision Date1993-07-20

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