NOVA FA DR SYSTEM

Solid State X-ray Imager (flat Panel/digital Imager)

SEDECAL SA

The following data is part of a premarket notification filed by Sedecal Sa with the FDA for Nova Fa Dr System.

Pre-market Notification Details

Device IDK133782
510k NumberK133782
Device Name:NOVA FA DR SYSTEM
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant SEDECAL SA 8870 RAVELLO CT. Naples,  FL  34114
ContactDaniel Kamm, P.e.
CorrespondentDaniel Kamm, P.e.
SEDECAL SA 8870 RAVELLO CT. Naples,  FL  34114
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-12
Decision Date2014-03-21
Summary:summary

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