LINEAR SCANNER PROBE ELSCINT LTD. TL-35

Phantom, Anthropomorphic, Nuclear

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Linear Scanner Probe Elscint Ltd. Tl-35.

Pre-market Notification Details

Device IDK844189
510k NumberK844189
Device Name:LINEAR SCANNER PROBE ELSCINT LTD. TL-35
ClassificationPhantom, Anthropomorphic, Nuclear
Applicant ELSCINT, INC. 775 NICHOLAS BLVD. Elk Grove Village,  IL  60007
ContactRobert E Kenney
CorrespondentRobert E Kenney
ELSCINT, INC. 775 NICHOLAS BLVD. Elk Grove Village,  IL  60007
Product CodeIYP  
CFR Regulation Number892.1370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-10-30
Decision Date1985-02-25

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