Device Classification Name |
electrocardiograph
|
510(k) Number |
K133985 |
Device Name |
DIGITAL ELECTROCARDIOGRAPH |
Applicant |
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. |
P.O. BOX 120-119 |
shanghai,
CN
200120
|
|
Applicant Contact |
diana hong |
Correspondent |
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. |
P.O. BOX 120-119 |
shanghai,
CN
200120
|
|
Correspondent Contact |
diana hong |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 12/26/2013 |
Decision Date | 01/22/2015 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|