INFINION SOFTWARE FEATURES

System, Nuclear Magnetic Resonance Imaging

PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.

The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Infinion Software Features.

Pre-market Notification Details

Device IDK024066
510k NumberK024066
Device Name:INFINION SOFTWARE FEATURES
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland,  OH  44143
ContactDuane Praschan
CorrespondentDuane Praschan
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland,  OH  44143
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-09
Decision Date2003-02-04
Summary:summary

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