Device Classification Name |
Analyzer, Body Composition
|
510(k) Number |
K101807 |
Device Name |
STAYHEALTHY BODY COMPOSITION MONITOR-BCM |
Applicant |
STAYHEALTHY, INC. |
724 E. HUNTINGTON DRIVE |
MONROVIA,
CA
91016
|
|
Applicant Contact |
JESUS FARINAS |
Correspondent |
STAYHEALTHY, INC. |
724 E. HUNTINGTON DRIVE |
MONROVIA,
CA
91016
|
|
Correspondent Contact |
JESUS FARINAS |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 06/28/2010 |
Decision Date | 01/26/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Clinical Trials |
NCT01209923 NCT01209936
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|