The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Gc70.
Device ID | K163115 |
510k Number | K163115 |
Device Name: | GC70 |
Classification | System, X-ray, Stationary |
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 | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-11-07 |
Decision Date | 2016-12-07 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GC70 79181598 5143847 Live/Registered |
Hyundai Motor Company 2015-12-31 |