Device Classification Name |
electrode, cutaneous
|
510(k) Number |
K171722 |
Device Name |
Electrodes with snap / Electrodes with pigtail |
Applicant |
Shenzhen Konmed Technology Co., Ltd |
703B, Haide building A, Nanxin Road, Nanshan |
Shenzhen,
CN
518000
|
|
Applicant Contact |
Tony Tony |
Correspondent |
Guangzhou GLOMED Biological Technology Co., Ltd. |
Suite 306, Kecheng Mansion, No.121 Science Road |
Guangzhou Science Park |
Guangzhou,
CN
510006
|
|
Correspondent Contact |
Cecilia Ceng |
Regulation Number | 882.1320
|
Classification Product Code |
|
Date Received | 06/12/2017 |
Decision Date | 01/10/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|