FDA 510(k) Applications for Medical Device Product Code "FAP"
(Cystometric Gas (Carbon-Dioxide) On Hydraulic Device)

FDA 510(k) Number Applicant Device Name Decision Date
K974775 AIRTRONIC SERVICES, INC. SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE 02/19/1998
K113771 NEUROVISION MEDICAL PRODUCTS, INC. SIGNAL GEAR URETHRAL CATHETER ELECTRODE 12/13/2012
K962472 RUSCH INTL. RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER 08/27/1996
K963330 SYNECTICS MEDICAL, INC. URODYNAMIC ANALYSIS MODULE 04/03/1997


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