GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102

System, Nuclear Magnetic Resonance Imaging

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Gyrex 2t Prestige Model No. 100-6321-0107 And Gyrex Privilege Model No. 100-6326-0102.

Pre-market Notification Details

Device IDK965044
510k NumberK965044
Device Name:GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102
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 Received1996-12-13
Decision Date1997-06-16
Summary:summary

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