MasteRad MX30

System, X-ray, Stationary

MedicaTech USA

The following data is part of a premarket notification filed by Medicatech Usa with the FDA for Masterad Mx30.

Pre-market Notification Details

Device IDK190601
510k NumberK190601
Device Name:MasteRad MX30
ClassificationSystem, X-ray, Stationary
Applicant MedicaTech USA 50 Maxwell Irvine,  CA  92618
ContactGeorge Makar
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-08
Decision Date2019-04-25

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