HRSW OPTION FOR CT TWIN FLASH

System, X-ray, Tomography, Computed

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Hrsw Option For Ct Twin Flash.

Pre-market Notification Details

Device IDK945512
510k NumberK945512
Device Name:HRSW OPTION FOR CT TWIN FLASH
ClassificationSystem, X-ray, Tomography, Computed
Applicant ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
ContactKathleen A Murray
CorrespondentKathleen A Murray
ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-09
Decision Date1995-03-14

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