Device Classification Name |
analyzer, body composition
|
510(k) Number |
K070999 |
Device Name |
BC (BODY COMPOSITION SOFTWARE) |
Applicant |
RJL SYSTEMS, INC. |
33939 HARPER AVE. |
CLINTON TWP,
MI
48035
|
|
Applicant Contact |
BARRY CALLAHAN |
Correspondent |
RJL SYSTEMS, INC. |
33939 HARPER AVE. |
CLINTON TWP,
MI
48035
|
|
Correspondent Contact |
BARRY CALLAHAN |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 04/09/2007 |
Decision Date | 08/02/2007 |
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
|
|
|