TRANSRECTAL PROBE BD65S-TR

System, Imaging, Pulsed Echo, Ultrasonic

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Transrectal Probe Bd65s-tr.

Pre-market Notification Details

Device IDK880219
510k NumberK880219
Device Name:TRANSRECTAL PROBE BD65S-TR
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 Received1988-01-20
Decision Date1988-03-31

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