Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K121025 |
Device Name |
YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION |
Applicant |
YA HORNG ELECTRONIC CO., LTD. |
NO. 58, FU-CHIUN ST. |
HSIN-CHU CITY,
TW
30067
|
|
Applicant Contact |
JEN KE-MIN |
Correspondent |
YA HORNG ELECTRONIC CO., LTD. |
NO. 58, FU-CHIUN ST. |
HSIN-CHU CITY,
TW
30067
|
|
Correspondent Contact |
JEN KE-MIN |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 04/04/2012 |
Decision Date | 08/17/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|