| Device Classification Name |
Analyzer, Body Composition
|
| 510(k) Number |
K010706 |
| Device Name |
THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER |
| Applicant |
| Measurement Specialties, Inc. |
| 21911 Erie Ln. |
|
Lake Forest,
CA
92630
|
|
| Applicant Contact |
CAROL PATTERSON |
| Correspondent |
| Measurement Specialties, Inc. |
| 21911 Erie Ln. |
|
Lake Forest,
CA
92630
|
|
| Correspondent Contact |
CAROL PATTERSON |
| Regulation Number | 870.2770 |
| Classification Product Code |
|
| Date Received | 03/09/2001 |
| Decision Date | 10/05/2001 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|