ESP 3-PHASE X-RAY GENERATORS

Generator, High-voltage, X-ray, Diagnostic

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Esp 3-phase X-ray Generators.

Pre-market Notification Details

Device IDK884678
510k NumberK884678
Device Name:ESP 3-PHASE X-RAY GENERATORS
ClassificationGenerator, High-voltage, X-ray, Diagnostic
Applicant ELSCINT, INC. 751 EXPRESSWAY DR. Itasca,  IL  60143
ContactRobert E Kenney
CorrespondentRobert E Kenney
ELSCINT, INC. 751 EXPRESSWAY DR. Itasca,  IL  60143
Product CodeIZO  
CFR Regulation Number892.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-08
Decision Date1989-01-17

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