Device Classification Name |
Electrocardiograph
|
510(k) Number |
K113485 |
Device Name |
ELECTROCARDIOGRAPH |
Applicant |
SHENZHEN CAREWELL ELECTRONICS CO., LTD |
P.O. BOX 237-023 |
SHANGHAI,
CN
200030
|
|
Applicant Contact |
Diana Hong |
Correspondent |
SHENZHEN CAREWELL ELECTRONICS CO., LTD |
P.O. BOX 237-023 |
SHANGHAI,
CN
200030
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 11/23/2011 |
Decision Date | 04/25/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|