Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K161886 |
Device Name |
Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device |
Applicant |
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD |
ZONE B, No.105, DONGLI ROAD, TORCH DEVELOPMENT DISTRICT |
ZHONGSHAN,
CN
528437
|
|
Applicant Contact |
ADA ZHANG |
Correspondent |
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD |
ZONE B, No.105, DONGLI ROAD, TORCH DEVELOPMENT DISTRICT |
ZHONGSHAN,
CN
528437
|
|
Correspondent Contact |
ADA ZHANG |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 07/11/2016 |
Decision Date | 10/14/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|