ESI-5000

System, Imaging, Pulsed Doppler, Ultrasonic

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Esi-5000.

Pre-market Notification Details

Device IDK935024
510k NumberK935024
Device Name:ESI-5000
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
ContactRochelle M Sobel
CorrespondentRochelle M Sobel
ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
Product CodeIYN  
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-20
Decision Date1996-06-12
Summary:summary

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