INRATIO 2 PT MONITORING SYSTEM


Device Classification Name

test, time, prothrombin

510(k) Number K072727
Device Name INRATIO 2 PT MONITORING SYSTEM
Applicant
HEMOSENSE, INC.
651 river oaks parkway
san jose, 
CA 
95134

Applicant Contact doug rundle
Correspondent
HEMOSENSE, INC.
651 river oaks parkway
san jose, 
CA 
95134

Correspodent Contact doug rundle
Regulation Number 864.7750
Classification Product Code
GJS  
Date Received 09/26/2007
Decision Date 10/26/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls