HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM


Device Classification Name

subsystem, water purification

510(k) Number K022747
Device Name HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM
Original Applicant
HYDROPURE SYSTEMS, INC.
3319 bartlett blvd.
orlando, 
FL 
32817

Original Contact robert v price
Regulation Number 876.5665
Classification Product Code
FIP  
Date Received 08/19/2002
Decision Date 02/11/2003
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