The following data is part of a premarket notification filed by Samsung Electronics Co.,ltd. with the FDA for Gc85a.
Device ID | K172229 |
510k Number | K172229 |
Device Name: | GC85A |
Classification | System, X-ray, Stationary |
Applicant | Samsung Electronics Co.,Ltd. 129, Samsung-Ro, Yeongtong-Gu Suwon-si, KR 16677 |
Contact | Jaesang Noh |
Correspondent | Jaesang Noh Samsung Electronics Co.,Ltd. 129, Samsung-Ro, Yeongtong-Gu Suwon-si, KR 16677 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-25 |
Decision Date | 2017-11-22 |
Summary: | summary |