THD Procto Software System

System, Imaging, Pulsed Echo, Ultrasonic

THD SpA

The following data is part of a premarket notification filed by Thd Spa with the FDA for Thd Procto Software System.

Pre-market Notification Details

Device IDK211623
510k NumberK211623
Device Name:THD Procto Software System
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant THD SpA Via Dell'Industria, 1 Correggio,  IT 42015
ContactMaurizio Pantaleoni
CorrespondentMaurizio Pantaleoni
THD SpA Via Dell'Industria, 1 Correggio,  IT 42015
Product CodeIYO  
Subsequent Product CodeFWG
Subsequent Product CodeITX
Subsequent Product CodeKLA
Subsequent Product CodeNSX
Subsequent Product CodeOUG
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-26
Decision Date2021-06-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18033737712389 K211623 000
08033737713037 K211623 000

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