Device Classification Name |
analyzer, body composition
|
510(k) Number |
K122976 |
Device Name |
BODY FAT SCALE MODEL SF-371 |
Applicant |
SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE |
77325 JOYCE WAY |
ECHO,
OR
97826
|
|
Applicant Contact |
CHARLIE MACK |
Correspondent |
SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE |
77325 JOYCE WAY |
ECHO,
OR
97826
|
|
Correspondent Contact |
CHARLIE MACK |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 09/26/2012 |
Decision Date | 01/04/2013 |
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
|
|
|