Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K172739 |
Device Name |
higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) |
Applicant |
higi SH LLC |
800 Royal Oaks Dr. |
Suite 102 and 106 |
Monrovia,
CA
91016
|
|
Applicant Contact |
Colin Hill |
Correspondent |
higi SH LLC |
800 Royal Oaks Dr. |
Suite 102 and 106 |
Monrovia,
CA
91016
|
|
Correspondent Contact |
Colin Hill |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 09/12/2017 |
Decision Date | 10/10/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|