ESI-1002 SYSTEM AND DC100S/C50M-P TRANSDUCER

System, Imaging, Pulsed Echo, Ultrasonic

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Esi-1002 System And Dc100s/c50m-p Transducer.

Pre-market Notification Details

Device IDK870964
510k NumberK870964
Device Name:ESI-1002 SYSTEM AND DC100S/C50M-P TRANSDUCER
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant ELSCINT, INC. 751 EXPRESSWAY DR. Itasca,  IL  60143
ContactRobert E Kenney
CorrespondentRobert E Kenney
ELSCINT, INC. 751 EXPRESSWAY DR. Itasca,  IL  60143
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-03-10
Decision Date1987-03-13

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