THD REVOLUTION

Monitor, Ultrasonic, Nonfetal

THD SPA

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

Pre-market Notification Details

Device IDK141657
510k NumberK141657
Device Name:THD REVOLUTION
ClassificationMonitor, Ultrasonic, Nonfetal
Applicant THD SPA VIA A. BONETTI 3/A Imola, Bo,  IT 40026
ContactMaurizio Pantaleoni
CorrespondentMaurizio Pantaleoni
THD SPA VIA A. BONETTI 3/A Imola, Bo,  IT 40026
Product CodeJAF  
CFR Regulation Number892.1540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-20
Decision Date2015-02-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18033737710842 K141657 000

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