IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400


Device Classification Name

monitor, extracellular fluid, lymphedema, extremity

510(k) Number K080825
Device Name IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400
Applicant
IMPEDIMED PTY LTD.
unit 1, 50 parker court
pinkenba, qld, 

AU

4008

Applicant Contact philip s auckland
Correspondent
IMPEDIMED PTY LTD.
unit 1, 50 parker court
pinkenba, qld, 

AU

4008

Correspodent Contact philip s auckland
Regulation Number 870.2770
Classification Product Code
OBH  
Date Received 03/24/2008
Decision Date 10/03/2008
Decision

substantially equivalent – kit

(SESK)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No