GYRES 2T PRESTIGE

System, Nuclear Magnetic Resonance Imaging

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Gyres 2t Prestige.

Pre-market Notification Details

Device IDK945791
510k NumberK945791
Device Name:GYRES 2T PRESTIGE
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
ContactThomas J Spackman
CorrespondentThomas J Spackman
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 Received1994-11-25
Decision Date1995-09-19

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