| Device Classification Name |
Analyzer, Body Composition
|
| 510(k) Number |
K060538 |
| Device Name |
BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563 AND 9568 |
| Applicant |
| Beaverite International Limited |
| 5600 Wisconsin Ave. |
| Suite,509 |
|
Chevy Chase,
MD
20815
|
|
| Applicant Contact |
PATSY J TRISLER |
| Correspondent |
| Beaverite International Limited |
| 5600 Wisconsin Ave. |
| Suite,509 |
|
Chevy Chase,
MD
20815
|
|
| Correspondent Contact |
PATSY J TRISLER |
| Regulation Number | 870.2770 |
| Classification Product Code |
|
| Date Received | 02/28/2006 |
| Decision Date | 10/10/2006 |
| 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
|
Predetermined Change Control Plan Authorized |
No
|
|
|