The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Gr40cw.
Device ID | K152094 |
510k Number | K152094 |
Device Name: | GR40CW |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO, YEONGTONG-GU Suwon-si, KR 443-742 |
Contact | Chulsin Kim |
Correspondent | Chulsin Kim SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO, YEONGTONG-GU Suwon-si, KR 443-742 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-28 |
Decision Date | 2015-10-16 |
Summary: | summary |