SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare

Snare, Flexible

Intelligent Endoscopy

The following data is part of a premarket notification filed by Intelligent Endoscopy with the FDA for Smartband Emr Kit, Smartband Emr Pack, Smartsnare.

Pre-market Notification Details

Device IDK190512
501k NumberK190512
Device Name:SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare
ClassificationSnare, Flexible
Applicant Intelligent Endoscopy 4740 Commercial Park Ct, Suite 1 Clemmons,  NC  27012
ContactMelissa Clark
CorrespondentMelissa Clark
Intelligent Endoscopy 4740 Commercial Park Ct, Suite 1 Clemmons,  NC  27012
Product CodeFDI  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
501k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-01
Decision Date2019-11-22

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