Device Classification Name |
Monitor, Extracellular Fluid, Lymphedema, Extremity
|
510(k) Number |
K130338 |
Device Name |
IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS |
Applicant |
IMPEDIMED LIMITED |
555 13TH STREET, NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
John j Smith, M.D., J.D. |
Correspondent |
IMPEDIMED LIMITED |
555 13TH STREET, NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
John j Smith, M.D., J.D. |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 02/11/2013 |
Decision Date | 05/31/2013 |
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
|
|
|