THD Anopress With THD SensyProbe

Monitor, Esophageal Motility, And Tube

THD SpA

The following data is part of a premarket notification filed by Thd Spa with the FDA for Thd Anopress With Thd Sensyprobe.

Pre-market Notification Details

Device IDK180135
510k NumberK180135
Device Name:THD Anopress With THD SensyProbe
ClassificationMonitor, Esophageal Motility, And Tube
Applicant THD SpA Via Dell'Industria 1 Correggio,  IT 42015
ContactMaurizio Pantaleoni
CorrespondentMaurizio Pantaleoni
THD SpA Via Dell'Industria 1 Correggio,  IT 42015
Product CodeKLA  
CFR Regulation Number876.1725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-17
Decision Date2018-03-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08033737712306 K180135 000
08033737712290 K180135 000

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