C015

Interventional Fluoroscopic X-ray System

Micronica SRL

The following data is part of a premarket notification filed by Micronica Srl with the FDA for C015.

Pre-market Notification Details

Device IDK192182
510k NumberK192182
Device Name:C015
ClassificationInterventional Fluoroscopic X-ray System
Applicant Micronica SRL Via Augusto Righi, 30 Mirandola,  IT 41037
ContactMassimo Tomasi
CorrespondentMarisa Testa
Thema S.r.l. Via Saragat,5 Imola,  IT 40026
Product CodeOWB  
Subsequent Product CodeJAA
Subsequent Product CodeLMC
Subsequent Product CodeOXO
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-12
Decision Date2020-01-17

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