Device Classification Name |
Analyzer, Body Composition
|
510(k) Number |
K120896 |
Device Name |
WI-FI BODY SCALE |
Applicant |
ANDON HEALTH CO., LTD |
No. 3 Jin Ping Street,Ya An Road, |
NANKAI DISTRICT |
TIANJIN,
CN
300190
|
|
Applicant Contact |
LIU YI |
Correspondent |
ANDON HEALTH CO., LTD |
No. 3 Jin Ping Street,Ya An Road, |
NANKAI DISTRICT |
TIANJIN,
CN
300190
|
|
Correspondent Contact |
LIU YI |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 03/26/2012 |
Decision Date | 07/26/2012 |
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
|
|
|