Device Classification Name |
Analyzer, Body Composition
|
510(k) Number |
K062043 |
Device Name |
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500 |
Applicant |
OMRON HEALTHCARE, INC. |
3460 POINTE CREEK COURT #102 |
BONITA SPRINGS,
FL
34134
|
|
Applicant Contact |
DONNA DJINOVICH |
Correspondent |
OMRON HEALTHCARE, INC. |
3460 POINTE CREEK COURT #102 |
BONITA SPRINGS,
FL
34134
|
|
Correspondent Contact |
DONNA DJINOVICH |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 07/19/2006 |
Decision Date | 11/07/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|