ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711


Device Classification Name

computer, diagnostic, pre-programmed, single-function

510(k) Number K021874
Device Name ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711
Original Applicant
ABBOTT LABORATORIES
200 abbott park rd.
abbott park, 
IL 
60064 -6157

Original Contact frank pokrop
Regulation Number 870.1435
Classification Product Code
DXG  
Subsequent Product Code
DQA  
Date Received 06/07/2002
Decision Date 07/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No