The following data is part of a premarket notification filed by Gemss Medical Systems Co., Ltd with the FDA for Gemss Medical System Surgical Mobile Fluoroscopic X-ray System.
| Device ID | K160065 |
| 510k Number | K160065 |
| Device Name: | GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | GEMSS MEDICAL SYSTEMS CO., LTD 2nd Floor, 29, Dunchon-daero 541 Beon-gil, Jungwon-gu Seongnam-si, KR 13216 |
| Contact | Sang Woo Lee |
| Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-13 |
| Decision Date | 2016-05-20 |
| Summary: | summary |