Device Classification Name |
Monitor, Extracellular Fluid, Lymphedema, Extremity
More FDA Info for this Device |
510(K) Number |
K130338 |
Device Name |
Monitor, Extracellular Fluid, Lymphedema, Extremity |
Applicant |
IMPEDIMED LIMITED
555 13TH STREET, NW
WASHINGTON, DC 20004 US
Other 510(k) Applications for this Company
|
Contact |
John j Smith, M.D., J.D.
Other 510(k) Applications for this Contact |
Regulation Number |
870.2770
More FDA Info for this Regulation Number |
Classification Product Code |
OBH
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
02/11/2013 |
Decision Date |
05/31/2013 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CV - Cardiovascular |
Review Advisory Committee |
GU - Gastroenterology & Urology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|