MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY


Device Classification Name

pump, infusion

510(k) Number K073051
Device Name MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY
Applicant
MEDRAD, INC.
one medrad dr.
indianola, 
PA 
15051

Applicant Contact leslie s o’nan
Correspondent
MEDRAD, INC.
one medrad dr.
indianola, 
PA 
15051

Correspodent Contact leslie s o’nan
Regulation Number 880.5725
Classification Product Code
FRN  
Date Received 10/29/2007
Decision Date 05/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls