The following data is part of a premarket notification filed by Sg Healthcare Co Ltd with the FDA for Jumong Series.
| Device ID | K150816 |
| 510k Number | K150816 |
| Device Name: | Jumong Series |
| Classification | System, X-ray, Stationary |
| Applicant | SG HEALTHCARE CO LTD 753 ITECO, 150 JOJEONG-DAERO Hanam-si Gyeonggi-do, KR 465-736 |
| Contact | Yosep Park |
| Correspondent | Daniel Kamm KAMM & ASSOCIATES 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-27 |
| Decision Date | 2015-05-08 |
| Summary: | summary |