Device Classification Name |
Analyzer, Body Composition
|
510(k) Number |
K121971 |
Device Name |
WITHINGS, SMART BODY SCALE |
Applicant |
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
NO. 1 FANGHUA STREET |
HI-TECH DISTRICT |
CHENGDU, SICHUAN,
CN
610041
|
|
Applicant Contact |
LEO WANG |
Correspondent |
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
NO. 1 FANGHUA STREET |
HI-TECH DISTRICT |
CHENGDU, SICHUAN,
CN
610041
|
|
Correspondent Contact |
LEO WANG |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 07/05/2012 |
Decision Date | 09/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|