HEAD AND NECK COIL FOR THE GYREX 2T-DLX

System, Nuclear Magnetic Resonance Imaging

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Head And Neck Coil For The Gyrex 2t-dlx.

Pre-market Notification Details

Device IDK943320
510k NumberK943320
Device Name:HEAD AND NECK COIL FOR THE GYREX 2T-DLX
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
ContactK. Murray
CorrespondentK. Murray
ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-11
Decision Date1994-11-29

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