2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)

Coil, Magnetic Resonance, Specialty

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for 2t Prestige(100-6321-0107)/privilege(100-6326-0102)/gyrex V-ep(100-6327-0101).

Pre-market Notification Details

Device IDK972592
510k NumberK972592
Device Name:2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)
ClassificationCoil, Magnetic Resonance, Specialty
Applicant ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
ContactBeny Sherer
CorrespondentBeny Sherer
ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-11
Decision Date1997-09-15
Summary:summary

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