Device Classification Name |
analyzer, body composition
|
510(k) Number |
K123228 |
Device Name |
INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) |
Applicant |
BIOSPACE CORPORATION LIMITED |
8870 RAVELLO CT |
NAPLES,
FL
34114
|
|
Applicant Contact |
DANIEL KAMM |
Correspondent |
BIOSPACE CORPORATION LIMITED |
8870 RAVELLO CT |
NAPLES,
FL
34114
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 10/15/2012 |
Decision Date | 03/08/2013 |
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
|
|
|