Device Classification Name |
analyzer, body composition
|
510(k) Number |
K102191 |
Device Name |
TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER |
Applicant |
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
NO. 1 FANGHUA STREET |
HI-TECH DISTRICT |
CHENGDU,
CN
610041
|
|
Applicant Contact |
LEO WANG |
Correspondent |
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
NO. 1 FANGHUA STREET |
HI-TECH DISTRICT |
CHENGDU,
CN
610041
|
|
Correspondent Contact |
LEO WANG |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 08/03/2010 |
Decision Date | 05/02/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Abbreviated
|
Clinical Trials |
NCT01296048
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|