Device Classification Name |
Analyzer, Body Composition
|
510(k) Number |
K014009 |
Device Name |
TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE |
Applicant |
TANITA CORP. OF AMERICA |
2625 SOUTH CLEARBROOK DR. |
ARLINGTON HGTS.,
IL
60005
|
|
Applicant Contact |
CAROL ALLOIAN (BENSON) |
Correspondent |
TANITA CORP. OF AMERICA |
2625 SOUTH CLEARBROOK DR. |
ARLINGTON HGTS.,
IL
60005
|
|
Correspondent Contact |
CAROL ALLOIAN (BENSON) |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 12/05/2001 |
Decision Date | 06/24/2002 |
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
|
|
|