UltraLinq

System, Image Processing, Radiological

ULTRALINQ HEALTHCARE SOLUTIONS, INC.

The following data is part of a premarket notification filed by Ultralinq Healthcare Solutions, Inc. with the FDA for Ultralinq.

Pre-market Notification Details

Device IDK143176
510k NumberK143176
Device Name:UltraLinq
ClassificationSystem, Image Processing, Radiological
Applicant ULTRALINQ HEALTHCARE SOLUTIONS, INC. 236 West 30th Street, 15th Floor New York,  NY  10001
ContactStephen Farber
CorrespondentRita King
MethodSense, Inc. PO Box 110352 Durham,  NC  27709
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-04
Decision Date2015-07-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00862894000302 K143176 000
00862894000319 K143176 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.