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 |