SIGNAL GEAR URETHRAL CATHETER ELECTRODE

Cystometric Gas (carbon-dioxide) On Hydraulic Device

NEUROVISION MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Neurovision Medical Products, Inc. with the FDA for Signal Gear Urethral Catheter Electrode.

Pre-market Notification Details

Device IDK113771
510k NumberK113771
Device Name:SIGNAL GEAR URETHRAL CATHETER ELECTRODE
ClassificationCystometric Gas (carbon-dioxide) On Hydraulic Device
Applicant NEUROVISION MEDICAL PRODUCTS, INC. 2225 SPERRY AVE SUITE 1000 Ventura,  CA  93003
ContactChristine Vergely
CorrespondentChristine Vergely
NEUROVISION MEDICAL PRODUCTS, INC. 2225 SPERRY AVE SUITE 1000 Ventura,  CA  93003
Product CodeFAP  
CFR Regulation Number876.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-22
Decision Date2012-12-13
Summary:summary

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