BOLUSPRO ULTRA


the company

Device Classification Name

system, x-ray, tomography, computed

510(k) Number K002005
Device Name BOLUSPRO ULTRA
Original Applicant
MARCONI MEDICAL SYSTEMS, INC.
5595 miner rd.
highland heights, 
OH 
44143

Original Contact robert l turocy
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 07/03/2000
Decision Date 09/22/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No