Device Classification Name |
Analyzer, Body Composition
|
510(k) Number |
K130856 |
Device Name |
BIA / VITALITY ANALYZER |
Applicant |
IPGDX, LLC |
33 Golden Eagle Lane |
Littleton,
CO
80127
|
|
Applicant Contact |
Kevin Walls |
Correspondent |
IPGDX, LLC |
33 Golden Eagle Lane |
Littleton,
CO
80127
|
|
Correspondent Contact |
Kevin Walls |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 03/28/2013 |
Decision Date | 11/25/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|