AMX-III

System, X-ray, Mobile

GENERAL ELECTRIC CO.

The following data is part of a premarket notification filed by General Electric Co. with the FDA for Amx-iii.

Pre-market Notification Details

Device IDK802047
510k NumberK802047
Device Name:AMX-III
ClassificationSystem, X-ray, Mobile
Applicant GENERAL ELECTRIC CO. 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 Received1980-08-25
Decision Date1980-10-23

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