VOLMETRIC COINCIDENCE DETECTION SYSTEM

System, Tomography, Computed, Emission

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Volmetric Coincidence Detection System.

Pre-market Notification Details

Device IDK962100
510k NumberK962100
Device Name:VOLMETRIC COINCIDENCE DETECTION SYSTEM
ClassificationSystem, Tomography, Computed, Emission
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 CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-30
Decision Date1997-01-10

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