Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K153600 |
Device Name |
Consult Station TS |
Applicant |
H4D SAS |
92 AVENUE KLEBER |
PARIS,
FR
|
|
Applicant Contact |
MARTA RIVAS |
Correspondent |
VOISIN CONSULTING LIFE SCIENCES |
222 THIRD STREET |
SUITE 3121 |
Cambridge,
MA
02142
|
|
Correspondent Contact |
ESIN YESILALAN |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 12/16/2015 |
Decision Date | 03/17/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|