The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Xgeo Gr40cw.
Device ID | K140235 |
510k Number | K140235 |
Device Name: | XGEO GR40CW |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si, Gyeonggi-do, KR 443742 |
Contact | Jeongpyo Hong |
Correspondent | Jeongpyo Hong SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si, Gyeonggi-do, KR 443742 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-01-30 |
Decision Date | 2014-05-15 |
Summary: | summary |