Device Classification Name |
electrocardiograph
|
510(k) Number |
K152863 |
Device Name |
Portable ECG Monitor |
Applicant |
CONTEC MEDICAL SYSTEMS CO., LTD |
NO. 112 QINHUANG WEST STREET, ECONOMIC & |
TECHNICAL DEVELOPMENT ZONE |
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 | 09/30/2015 |
Decision Date | 06/22/2016 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|