Device Classification Name |
Cable, Transducer And Electrode, Patient, (Including Connector)
More FDA Info for this Device |
510(K) Number |
K200026 |
Device Name |
Cable, Transducer And Electrode, Patient, (Including Connector) |
Applicant |
Shenzhen Changke Connect Electronics Co., Ltd.
A2-4th floor of Xiang dali Technology Park,
No.87 of HengPing Road, Henggang,
Longgang District, Shenzhen 518000 CN
Other 510(k) Applications for this Company
|
Contact |
Yahui Zhou
Other 510(k) Applications for this Contact |
Regulation Number |
870.2900
More FDA Info for this Regulation Number |
Classification Product Code |
DSA
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
01/06/2020 |
Decision Date |
05/12/2020 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CV - Cardiovascular |
Review Advisory Committee |
CV - Cardiovascular |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|