Device Classification Name |
cable, transducer and electrode, patient, (including connector)
|
510(k) Number |
K191428 |
Device Name |
ECG Cable |
Applicant |
Shenzhen Changke Connect Electronics Co., Ltd. |
A2-4th floor of Xiang dali Technology Park |
No.87 of HengPing Road, Henggang |
Longgang District, Shenzhen,
CN
|
|
Applicant Contact |
Yahui Zhou |
Correspondent |
Shenzhen Changke Connect Electronics Co., Ltd. |
A2-4th floor of Xiang dali Technology Park |
No.87 of HengPing Road, Henggang |
Longgang District, Shenzhen,
CN
|
|
Correspondent Contact |
Yahui Zhou |
Regulation Number | 870.2900
|
Classification Product Code |
|
Date Received | 05/29/2019 |
Decision Date | 11/27/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|