WAVES


Device Classification Name

system, perfusion, kidney

510(k) Number K111521
Device Name WAVES
Applicant
WATERS MEDICAL SYSTEMS, LLC
2112 15th st. n.w., suite a
rochester, 
MN 
55901 -0716

Applicant Contact robert warren
Correspondent
WATERS MEDICAL SYSTEMS, LLC
2112 15th st. n.w., suite a
rochester, 
MN 
55901 -0716

Correspodent Contact robert warren
Regulation Number 876.5880
Classification Product Code
KDN  
Date Received 06/01/2011
Decision Date 02/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No