ZeeroMED View

System, Image Processing, Radiological

O3 Enterprise SRL

The following data is part of a premarket notification filed by O3 Enterprise Srl with the FDA for Zeeromed View.

Pre-market Notification Details

Device IDK200546
510k NumberK200546
Device Name:ZeeroMED View
ClassificationSystem, Image Processing, Radiological
Applicant O3 Enterprise SRL Padriciano 99 Tieste,  IT 34149
ContactAndrea Poli
CorrespondentJorge Millan
Sigma Biomedical 7600 NW 69th Avenue Medley,  FL  33166
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-03
Decision Date2020-05-05

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