Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K170497 |
Device Name |
V10 |
Applicant |
Mediana Co., Ltd. |
132, Donghwagongdan-ro, Munmak-eup |
Wonju-si,
KR
220-801
|
|
Applicant Contact |
Kim Min-hye |
Correspondent |
International Regulatory Consulatants |
7808 Rush Creek Drive |
Pasco,
WA
99301
|
|
Correspondent Contact |
Charlie Mack |
Regulation Number | 870.1130
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/17/2017 |
Decision Date | 12/15/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|