Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K200437 |
Device Name |
Blood Pressure Monitor |
Applicant |
Shenzhen Jamr Technology Co., Ltd. |
2nd Floor, A-building, No.2 Guiyuan Road, Guihua community, |
Guanlan town |
Shenzhen,
CN
518110
|
|
Applicant Contact |
Luo Fusheng |
Correspondent |
Shenzhen Jamr Technology Co., Ltd. |
2nd Floor, A-building, No.2 Guiyuan Road, Guihua community, |
Guanlan town |
Shenzhen,
CN
518110
|
|
Correspondent Contact |
Luo Fusheng |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 02/24/2020 |
Decision Date | 06/25/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|