APEX HELIX - A

System, Tomography, Computed, Emission

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Apex Helix - A.

Pre-market Notification Details

Device IDK914807
510k NumberK914807
Device Name:APEX HELIX - A
ClassificationSystem, Tomography, Computed, Emission
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 CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-25
Decision Date1992-02-27

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