ADVANCED AUTOMATIC KV

System, X-ray, Mammographic

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Advanced Automatic Kv.

Pre-market Notification Details

Device IDK934831
510k NumberK934831
Device Name:ADVANCED AUTOMATIC KV
ClassificationSystem, X-ray, Mammographic
Applicant ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
ContactRochelle M Sobel
CorrespondentRochelle M Sobel
ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
Product CodeIZH  
CFR Regulation Number892.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-08
Decision Date1994-08-23

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