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.
Device ID | K151219 |
510k Number | K151219 |
Device Name: | Models 2200DR And 1600DR Digital Stationary Radiographic Systems |
Classification | System, X-ray, Stationary |
Applicant | BEIJING POLYCON MEDICAL ENGINEERING COMPANY HAI DIAN QU BUILDING 9 FU WAI LIANG JIA DIAN Beijing, CN 100142 |
Contact | Xiangchen Liu |
Correspondent | Daniel Kamm KAMM & ASSOCIATES 8870 RAVELLO CT Naples, FL 34114 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-07 |
Decision Date | 2015-08-04 |
Summary: | summary |