CT PACE CATALOG NUMBER B7950A

System, X-ray, Tomography, Computed

GENERAL ELECTRIC CO.

The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ct Pace Catalog Number B7950a.

Pre-market Notification Details

Device IDK872526
510k NumberK872526
Device Name:CT PACE CATALOG NUMBER B7950A
ClassificationSystem, X-ray, Tomography, Computed
Applicant GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee,  WI  53201
ContactHoward, Ii
CorrespondentHoward, Ii
GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee,  WI  53201
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-25
Decision Date1987-09-23

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