The following data is part of a premarket notification filed by Ge Hualun Medical Systems Co.ltd. with the FDA for Oec Elite Miniview.
| Device ID | K171800 |
| 510k Number | K171800 |
| Device Name: | OEC Elite MiniView |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | GE Hualun Medical Systems Co.Ltd. No1 YongChang North Road, Beijing Economic Technological Development Zone Beijing, CN 100176 |
| Contact | Lifeng Wang |
| Correspondent | Lifeng Wang GE Hualun Medical Systems Co.Ltd. No1 YongChang North Road, Beijing Economic Technological Development Zone Beijing, CN 100176 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-16 |
| Decision Date | 2017-07-12 |
| Summary: | summary |