FDA 510(k) Applications Submitted by Samsung Electronics Co., Ltd.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K140332 |
02/10/2014 |
XGEO GU60A |
SAMSUNG ELECTRONICS CO., LTD. |
K181626 |
06/20/2018 |
Digital Diagnostic Mobile X-ray System |
Samsung Electronics Co., Ltd. |
K123098 |
10/02/2012 |
XGEO GC80 |
SAMSUNG ELECTRONICS CO., LTD. |
K123105 |
10/02/2012 |
XGEO GU60 |
SAMSUNG ELECTRONICS CO., LTD. |
K123106 |
10/02/2012 |
DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A |
SAMSUNG ELECTRONICS CO., LTD. |
K150097 |
01/20/2015 |
GM60A-32S & GM60A-40S |
SAMSUNG ELECTRONICS CO., LTD. |
K150165 |
01/26/2015 |
GC85A |
SAMSUNG ELECTRONICS CO., LTD. |
K140334 |
02/10/2014 |
XGEO GC80 |
SAMSUNG ELECTRONICS CO., LTD. |
K160997 |
04/11/2016 |
GC85A |
SAMSUNG ELECTRONICS CO., LTD. |
K151419 |
05/28/2015 |
GF50A |
SAMSUNG ELECTRONICS CO., LTD. |
K151685 |
06/22/2015 |
GUA60A, GU60A-65 |
SAMSUNG ELECTRONICS CO., LTD. |
K152094 |
07/28/2015 |
GR40CW |
SAMSUNG ELECTRONICS CO., LTD. |
K162278 |
08/15/2016 |
Digital Diagnostic Mobile X-ray System |
SAMSUNG ELECTRONICS CO., LTD. |
K163115 |
11/07/2016 |
GC70 |
SAMSUNG ELECTRONICS CO., LTD. |
K153401 |
11/24/2015 |
GR40CW |
SAMSUNG ELECTRONICS CO., LTD. |
K211139 |
04/16/2021 |
CUBE Air Purifier |
Samsung Electronics Co., Ltd. |
K222353 |
08/04/2022 |
GM85 |
Samsung Electronics Co., LTD. |
K182183 |
08/13/2018 |
GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A |
Samsung Electronics Co., LTD. |
K182622 |
09/24/2018 |
GU60A, GU60A-65 |
SAMSUNG ELECTRONICS CO., LTD. |
K182647 |
09/24/2018 |
GC70 |
Samsung Electronics Co., Ltd. |
K140326 |
02/10/2014 |
XGEO GF50 |
SAMSUNG ELECTRONICS CO., LTD. |
K140235 |
01/30/2014 |
XGEO GR40CW |
SAMSUNG ELECTRONICS CO., LTD. |
K142492 |
09/04/2014 |
GM60A-32S, GM60A-40S |
SAMSUNG ELECTRONICS CO., LTD. |
K143029 |
10/21/2014 |
Digital Diagnostic X-ray System (GC80) |
SAMSUNG ELECTRONICS CO., LTD. |
K213452 |
10/26/2021 |
GEMS-H |
Samsung Electronics Co., Ltd. |
K181629 |
06/20/2018 |
GC85A |
Samsung Electronics Co., Ltd. |
K181631 |
06/20/2018 |
GR40CW |
Samsung Electronics Co., Ltd. |
K132148 |
07/11/2013 |
S HEALTH |
SAMSUNG ELECTRONICS CO., LTD. |
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