HARMONY INR MONITORING SYSTEM


Device Classification Name

test, time, prothrombin

510(k) Number K022922
Device Name HARMONY INR MONITORING SYSTEM
Original Applicant
LIFESCAN, INC.
1000 gibraltar dr.
milpitas, 
CA 
95035 -6312

Original Contact john e hughes
Regulation Number 864.7750
Classification Product Code
GJS  
Date Received 09/04/2002
Decision Date 09/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No