Device Classification Name |
analyzer, body composition
|
510(k) Number |
K023478 |
Device Name |
INBODY AP1 BODY COMPOSITION ANALYZER |
Applicant |
BIOSPACE CO.,LTD |
PO BOX 7007 |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
DANIEL KAMM |
Correspondent |
BIOSPACE CO.,LTD |
PO BOX 7007 |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 10/16/2002 |
Decision Date | 05/13/2003 |
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
|
|
|