The following data is part of a premarket notification filed by Ge Hangwei Medical Systems Co., Ltd. with the FDA for Oec Elite Miniview.
| Device ID | K160131 |
| 510k Number | K160131 |
| Device Name: | OEC Elite MiniView |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | GE HANGWEI MEDICAL SYSTEMS CO., LTD. NO.1 YONGCHANG NORTH ROAD, BEIJING ECON.&TECH.DEV.ZONE Beijing, CN 100176 |
| Contact | Lifeng Wang |
| Correspondent | Lifeng Wang GE HANGWEI MEDICAL SYSTEMS CO., LTD. NO.1 YONGCHANG NORTH ROAD, BEIJING ECON.&TECH.DEV.ZONE Beijing, CN 100176 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-20 |
| Decision Date | 2016-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682118835 | K160131 | 000 |
| 00195278502582 | K160131 | 000 |