MOBILE X-RAY UNIT

System, X-ray, Mobile

GENERAL X-RAY, INC.

The following data is part of a premarket notification filed by General X-ray, Inc. with the FDA for Mobile X-ray Unit.

Pre-market Notification Details

Device IDK790511
510k NumberK790511
Device Name:MOBILE X-RAY UNIT
ClassificationSystem, X-ray, Mobile
Applicant GENERAL X-RAY, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-03-16
Decision Date1979-03-26

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