CP-SPINE COILS FOR GYREX 2T-DLX & V-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 Cp-spine Coils For Gyrex 2t-dlx & V-dlx.

Pre-market Notification Details

Device IDK934987
510k NumberK934987
Device Name:CP-SPINE COILS FOR GYREX 2T-DLX & V-DLX
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
ContactRochelle M Sobel
CorrespondentRochelle M Sobel
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 Received1993-10-18
Decision Date1994-09-16

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