UPRIGHT BUCKY STAND/MOUNT

System, X-ray, Stationary

X-RAY SYSTEMS

The following data is part of a premarket notification filed by X-ray Systems with the FDA for Upright Bucky Stand/mount.

Pre-market Notification Details

Device IDK855161
510k NumberK855161
Device Name:UPRIGHT BUCKY STAND/MOUNT
ClassificationSystem, X-ray, Stationary
Applicant X-RAY SYSTEMS 33061 GROESBECK HWY. Fraser,  MI  48026 -1514
ContactRichard Drumb
CorrespondentRichard Drumb
X-RAY SYSTEMS 33061 GROESBECK HWY. Fraser,  MI  48026 -1514
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-26
Decision Date1986-02-12

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