Device Classification Name |
Ultrasonic Body Composition Analyzer
|
510(k) Number |
K082147 |
Device Name |
BODYMETRIX BX2000 |
Applicant |
INTELAMETRIX, INC |
6246 PRESTON AVENUE |
LIVERMORE,
CA
94551
|
|
Applicant Contact |
HEIDI STARK |
Correspondent |
INTELAMETRIX, INC |
6246 PRESTON AVENUE |
LIVERMORE,
CA
94551
|
|
Correspondent Contact |
HEIDI STARK |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 07/30/2008 |
Decision Date | 03/20/2009 |
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
|
|
|