Device Classification Name |
analyzer, body composition
|
510(k) Number |
K062652 |
Device Name |
INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR |
Applicant |
TANITA CORPORATION OF AMERICA |
2625 SOUTH CLEARBROOK DRIVE |
ARLINGTON HEIGHTS,
IL
60005
|
|
Applicant Contact |
BETH MACKEY |
Correspondent |
TANITA CORPORATION OF AMERICA |
2625 SOUTH CLEARBROOK DRIVE |
ARLINGTON HEIGHTS,
IL
60005
|
|
Correspondent Contact |
BETH MACKEY |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 09/07/2006 |
Decision Date | 12/28/2006 |
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
|
|
|