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
|
|
|