Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K210563 |
Device Name |
Arm Blood Pressure Monitor |
Applicant |
Alicn Medical Shenzhen,Inc |
Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng |
Life Science Park, Kengzi |
Shenzhen,
CN
518118
|
|
Applicant Contact |
Fang Meisong |
Correspondent |
Alicn Medical Shenzhen,Inc |
Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng |
Life Science Park, Kengzi |
Shenzhen,
CN
518118
|
|
Correspondent Contact |
Fang Meisong |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 02/25/2021 |
Decision Date | 10/15/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|