UROGRAM CYSTOMETROGRAM

Device, Cystometric, Hydraulic

MYO/KINETIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Myo/kinetic Systems, Inc. with the FDA for Urogram Cystometrogram.

Pre-market Notification Details

Device IDK936041
510k NumberK936041
Device Name:UROGRAM CYSTOMETROGRAM
ClassificationDevice, Cystometric, Hydraulic
Applicant MYO/KINETIC SYSTEMS, INC. N84 W13562 LEON RD. Menomonee Falls,  WI  53051
ContactHassan Hamedi
CorrespondentHassan Hamedi
MYO/KINETIC SYSTEMS, INC. N84 W13562 LEON RD. Menomonee Falls,  WI  53051
Product CodeFEN  
CFR Regulation Number876.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-20
Decision Date1994-04-18

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