The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Gm60a-32s, Gm60a-40s.
Device ID | K142492 |
510k Number | K142492 |
Device Name: | GM60A-32S, GM60A-40S |
Classification | System, X-ray, Mobile |
Applicant | SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si, Gyeonggi-do, KR 443742 |
Contact | Kim Chulsin |
Correspondent | Kim Chulsin SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si, Gyeonggi-do, KR 443742 |
Product Code | IZL |
CFR Regulation Number | 892.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-04 |
Decision Date | 2014-12-17 |
Summary: | summary |