CARDIAC COMPUTATION SOFTWARE PACKAGE

Transducer, Ultrasonic

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Cardiac Computation Software Package.

Pre-market Notification Details

Device IDK890636
510k NumberK890636
Device Name:CARDIAC COMPUTATION SOFTWARE PACKAGE
ClassificationTransducer, Ultrasonic
Applicant ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
ContactM Sobel,esq
CorrespondentM Sobel,esq
ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
Product CodeJOP  
CFR Regulation Number870.2880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-08
Decision Date1989-08-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.