MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM


Device Classification Name

pump, infusion

510(k) Number K021988
Device Name MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM
Original Applicant
MEDRAD, INC.
one medrad dr.
indianola, 
PA 
15051

Original Contact lorraine r fredes
Regulation Number 880.5725
Classification Product Code
FRN  
Subsequent Product Code
FPA  
Date Received 06/18/2002
Decision Date 08/29/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Abbreviated
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls