MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL

System, Nuclear Magnetic Resonance Imaging

HITACHI MEDICAL SYSTEMS AMERICA, INC.

The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Mrp-5000 And 7000 Bilateral/unilateral Tmj Coil.

Pre-market Notification Details

Device IDK923140
510k NumberK923140
Device Name:MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant HITACHI MEDICAL SYSTEMS AMERICA, INC. 1963 CASE PKWY. Twinsburg,  OH  44087
ContactJochen Rogers
CorrespondentJochen Rogers
HITACHI MEDICAL SYSTEMS AMERICA, INC. 1963 CASE PKWY. Twinsburg,  OH  44087
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-29
Decision Date1992-12-24

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