HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)


Device Classification Name

analyzer, heparin, automated

510(k) Number K111339
Device Name HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
Applicant
MEDTRONIC INC.
8200 coral sea street ne
mounds view, 
MN 
55112

Applicant Contact amra racic
Correspondent
MEDTRONIC INC.
8200 coral sea street ne
mounds view, 
MN 
55112

Correspodent Contact amra racic
Regulation Number 864.5680
Classification Product Code
JOX  
Date Received 05/12/2011
Decision Date 06/08/2011
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