Models 2200DR And 1600DR Digital Stationary Radiographic Systems

System, X-ray, Stationary

BEIJING POLYCON MEDICAL ENGINEERING COMPANY

The following data is part of a premarket notification filed by Beijing Polycon Medical Engineering Company with the FDA for Models 2200dr And 1600dr Digital Stationary Radiographic Systems.

Pre-market Notification Details

Device IDK151219
510k NumberK151219
Device Name:Models 2200DR And 1600DR Digital Stationary Radiographic Systems
ClassificationSystem, X-ray, Stationary
Applicant BEIJING POLYCON MEDICAL ENGINEERING COMPANY HAI DIAN QU BUILDING 9 FU WAI LIANG JIA DIAN Beijing,  CN 100142
ContactXiangchen Liu
CorrespondentDaniel Kamm
KAMM & ASSOCIATES 8870 RAVELLO CT Naples,  FL  34114
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-07
Decision Date2015-08-04
Summary:summary

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