The following data is part of a premarket notification filed by Samsung Electronics Co.,ltd. with the FDA for Gm85.
| Device ID | K171119 |
| 510k Number | K171119 |
| Device Name: | GM85 |
| Classification | System, X-ray, Mobile |
| Applicant | Samsung Electronics Co.,Ltd. 129, Samsung-Ro, Yeongtong-Gu Suwon-si, KR 16677 |
| Contact | Chulsin Kim |
| Correspondent | Chulsin Kim Samsung Electronics Co.,Ltd. 129, Samsung-Ro, Yeongtong-Gu Suwon-si, KR 16677 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-14 |
| Decision Date | 2017-05-12 |
| Summary: | summary |