MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)


Device Classification Name

pump, infusion

510(k) Number K111386
Device Name MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
Applicant
SMITHS MEDICAL MD, INC.
1265 grey fox rd.
st. paul, 
MN 
55112

Applicant Contact james chapman
Correspondent
SMITHS MEDICAL MD, INC.
1265 grey fox rd.
st. paul, 
MN 
55112

Correspodent Contact james chapman
Regulation Number 880.5725
Classification Product Code
FRN  
Subsequent Product Code
MRZ  
Date Received 05/18/2011
Decision Date 08/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls