Device Classification Name |
system, x-ray, mobile
|
510(k) Number |
K142492 |
Device Name |
GM60A-32S, GM60A-40S |
Applicant |
SAMSUNG ELECTRONICS CO., LTD. |
129, SAMSUNG-RO |
YEONGTONG-GU |
SUWON-SI, GYEONGGI-DO,
KR
443742
|
|
Applicant Contact |
KIM CHULSIN |
Correspondent |
SAMSUNG ELECTRONICS CO., LTD. |
129, SAMSUNG-RO |
YEONGTONG-GU |
SUWON-SI, GYEONGGI-DO,
KR
443742
|
|
Correspondent Contact |
KIM CHULSIN |
Regulation Number | 892.1720
|
Classification Product Code |
|
Date Received | 09/04/2014 |
Decision Date | 12/17/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|