Device Classification Name |
Analyzer, Body Composition
|
510(k) Number |
K052319 |
Device Name |
IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7 |
Applicant |
IMPEDIMED PTY LTD. |
BUILDING 4B/2404 LOGAN ROAD |
EIGHT MILE PLAINS |
BRISBANE, QUEENSLAND,
AU
4113
|
|
Applicant Contact |
NEVILLE BERTWISTLE |
Correspondent |
IMPEDIMED PTY LTD. |
BUILDING 4B/2404 LOGAN ROAD |
EIGHT MILE PLAINS |
BRISBANE, QUEENSLAND,
AU
4113
|
|
Correspondent Contact |
NEVILLE BERTWISTLE |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 08/25/2005 |
Decision Date | 04/04/2006 |
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
|
|
|