X-RAY EQUIPMENT (VARIOUS TYPES)

System, X-ray, Fluoroscopic, Image-intensified

CONTINENTAL X-RAY CORP.

The following data is part of a premarket notification filed by Continental X-ray Corp. with the FDA for X-ray Equipment (various Types).

Pre-market Notification Details

Device IDK895730
510k NumberK895730
Device Name:X-RAY EQUIPMENT (VARIOUS TYPES)
ClassificationSystem, X-ray, Fluoroscopic, Image-intensified
Applicant CONTINENTAL X-RAY CORP. POST OFFICE BOX 5571 Chicago,  IL  60680
ContactRobert D Walker
CorrespondentRobert D Walker
CONTINENTAL X-RAY CORP. POST OFFICE BOX 5571 Chicago,  IL  60680
Product CodeJAA  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-09-22
Decision Date1989-11-06

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