Device Classification Name |
Transmitters And Receivers, Physiological Signal, Radiofrequency
|
510(k) Number |
K132148 |
FOIA Releasable 510(k) |
K132148
|
Device Name |
S HEALTH |
Applicant |
SAMSUNG ELECTRONICS CO., LTD. |
129, SAMSUNG-RO, |
YEONGTONG-GU |
SUWON-SI, GYEONGGI-DO,
KR
443-742
|
|
Applicant Contact |
Priscilla Chung |
Correspondent |
SAMSUNG ELECTRONICS CO., LTD. |
129, SAMSUNG-RO, |
YEONGTONG-GU |
SUWON-SI, GYEONGGI-DO,
KR
443-742
|
|
Correspondent Contact |
Priscilla Chung |
Regulation Number | 870.2910
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/11/2013 |
Decision Date | 12/04/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|