Device Classification Name |
electrocardiograph
|
510(k) Number |
K171360 |
Device Name |
CONTEC™ Electrocardiograph |
Applicant |
Contec Medical Systems Co., LTD. |
No. 112 QinHuang West Street |
Economic & Technical Development Zone |
qinhuangdao,
CN
066012
|
|
Applicant Contact |
xueyong li |
Correspondent |
Beijing Believe Technology Service Co., Ltd. |
5-402, Building #27, YangGuangYiShang, No.56, |
LiangXiang East Rd., |
fangshan dist,beijing,,
CN
102401
|
|
Correspondent Contact |
ray wang |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 05/09/2017 |
Decision Date | 01/22/2018 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|