MAGNETOM ESPREE SYSTEM

System, Nuclear Magnetic Resonance Imaging

SIEMENS MEDICAL SOLUTIONS USA, INC.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Magnetom Espree System.

Pre-market Notification Details

Device IDK041112
510k NumberK041112
Device Name:MAGNETOM ESPREE SYSTEM
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern,  PA  19355 -1406
ContactNealie Hartman
CorrespondentNealie Hartman
SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern,  PA  19355 -1406
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-28
Decision Date2004-07-21
Summary:summary

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