Device Classification Name |
analyzer, body composition
|
510(k) Number |
K060642 |
Device Name |
DUTECK BODY COMPOSITION ANALYZER |
Applicant |
DUTECK INDUSTRIAL CO., LTD. |
3F-2, NO. 26, 513 LANE |
JUI-KUANG ROAD |
TAIPEI,
TW
114
|
|
Applicant Contact |
JOSEPH CHEN |
Correspondent |
DUTECK INDUSTRIAL CO., LTD. |
3F-2, NO. 26, 513 LANE |
JUI-KUANG ROAD |
TAIPEI,
TW
114
|
|
Correspondent Contact |
JOSEPH CHEN |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 03/10/2006 |
Decision Date | 06/07/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|