PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9


Device Classification Name

computer, diagnostic, programmable

510(k) Number K023112
Device Name PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9
Original Applicant
PROBLEM SOLVING CONCEPTS, INC.
8020 castleway dr, suite 120
indianapolis, 
IN 
46250

Original Contact thomas m mcclelland
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 09/19/2002
Decision Date 12/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No