ESI-3000 ULTRASOUND SYSTEM

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-3000 Ultrasound System.

Pre-market Notification Details

Device IDK904359
510k NumberK904359
Device Name:ESI-3000 ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
ContactRochelle Sobel
CorrespondentRochelle 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 Received1990-09-24
Decision Date1991-03-05

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