IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION

Cystometric Gas (carbon-dioxide) On Hydraulic Device

BROWNE MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Browne Medical Systems, Inc. with the FDA for Image Pro Urodynamics Measuring Syst, Modification.

Pre-market Notification Details

Device IDK920991
510k NumberK920991
Device Name:IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION
ClassificationCystometric Gas (carbon-dioxide) On Hydraulic Device
Applicant BROWNE MEDICAL SYSTEMS, INC. 8990 SPRINGBROOK DRIVE, SUITE 120 Minneapolis,  MN  55433
ContactAl Sherwood
CorrespondentAl Sherwood
BROWNE MEDICAL SYSTEMS, INC. 8990 SPRINGBROOK DRIVE, SUITE 120 Minneapolis,  MN  55433
Product CodeFAP  
CFR Regulation Number876.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-02-14
Decision Date1992-04-10

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