DYNEX-44 DIAGNOSTIC ULTRASOUND IMAGING

System, Imaging, Pulsed Echo, Ultrasonic

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Dynex-44 Diagnostic Ultrasound Imaging.

Pre-market Notification Details

Device IDK812014
510k NumberK812014
Device Name:DYNEX-44 DIAGNOSTIC ULTRASOUND IMAGING
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant ELSCINT, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-07-17
Decision Date1981-09-16

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