MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U

System, X-ray, Tomography, Computed

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Modified Exel 2400 Elite/u & Exel 2400e/u.

Pre-market Notification Details

Device IDK900170
510k NumberK900170
Device Name:MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U
ClassificationSystem, X-ray, Tomography, Computed
Applicant ELSCINT, INC. 3550 SALT CREEK LN, STE. 105 Arlington Heights,  IL  60005
ContactRochelle M Sobel
CorrespondentRochelle M Sobel
ELSCINT, INC. 3550 SALT CREEK LN, STE. 105 Arlington Heights,  IL  60005
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-12
Decision Date1990-07-25

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