INTELLIO Tablet Application

Endoscopic Central Control Unit

Smith & Nephew

The following data is part of a premarket notification filed by Smith & Nephew with the FDA for Intellio Tablet Application.

Pre-market Notification Details

Device IDK192876
510k NumberK192876
Device Name:INTELLIO Tablet Application
ClassificationEndoscopic Central Control Unit
Applicant Smith & Nephew 150 Minuteman Rd Andover,  MA  01810
ContactJanice Haselton
CorrespondentJanice Haselton
Smith & Nephew 150 Minuteman Rd Andover,  MA  01810
Product CodeODA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGeneral & Plastic Surgery
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-08
Decision Date2020-02-27

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