Device Classification Name |
electrocardiograph
|
510(k) Number |
K170954 |
Device Name |
Portable ECG Monitor |
Applicant |
CONTEC Medical Systems Co.,Ltd |
No.112 Qinhuang West Street, Economic& Technical Development |
qinhuangdao,
CN
066004
|
|
Applicant Contact |
xueyong li |
Correspondent |
Mid-Link Consulting Co.,Ltd |
P.O. Box 120-119 |
shanghai,
CN
200120
|
|
Correspondent Contact |
diana hong |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 03/31/2017 |
Decision Date | 05/30/2017 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|