BOLUSPRO ULTRA

System, X-ray, Tomography, Computed

MARCONI MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Marconi Medical Systems, Inc. with the FDA for Boluspro Ultra.

Pre-market Notification Details

Device IDK002005
510k NumberK002005
Device Name:BOLUSPRO ULTRA
ClassificationSystem, X-ray, Tomography, Computed
Applicant MARCONI MEDICAL SYSTEMS, INC. 5595 MINER RD. Highland Heights,  OH  44143
ContactRobert L Turocy
CorrespondentRobert L Turocy
MARCONI MEDICAL SYSTEMS, INC. 5595 MINER RD. Highland Heights,  OH  44143
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-03
Decision Date2000-09-22

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