MEDRAD INTEGO PET INFUSION SYSTEM


Device Classification Name

pump, infusion

510(k) Number K080297
Device Name MEDRAD INTEGO PET INFUSION SYSTEM
Applicant
MEDRAD, INC.
one medrad dr.
indianola, 
PA 
15051

Applicant Contact troy a jack
Correspondent
MEDRAD, INC.
one medrad dr.
indianola, 
PA 
15051

Correspodent Contact troy a jack
Regulation Number 880.5725
Classification Product Code
FRN  
Date Received 02/04/2008
Decision Date 06/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No