TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM

System, Imaging, Pulsed Echo, Ultrasonic

ENVISIONEERING, LLC.

The following data is part of a premarket notification filed by Envisioneering, Llc. with the FDA for Targetscn Transrectal Ultrasound System.

Pre-market Notification Details

Device IDK041639
510k NumberK041639
Device Name:TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant ENVISIONEERING, LLC. 1982 INNERBELT BUSINESS CTR DR St. Louis,  MO  63114
ContactTom Kappel
CorrespondentSilvia Ankova
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-06-17
Decision Date2004-09-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00852656007069 K041639 000

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