B-350 CEILING MOUNTED C-POSITIONER

System, X-ray, Fluoroscopic, Image-intensified

OMEGA MEDICAL IMAGING, INC.

The following data is part of a premarket notification filed by Omega Medical Imaging, Inc. with the FDA for B-350 Ceiling Mounted C-positioner.

Pre-market Notification Details

Device IDK970947
510k NumberK970947
Device Name:B-350 CEILING MOUNTED C-POSITIONER
ClassificationSystem, X-ray, Fluoroscopic, Image-intensified
Applicant OMEGA MEDICAL IMAGING, INC. 675 HICKMAN CIRCLE Sanford,  FL  32771
ContactDouglas Coon
CorrespondentDouglas Coon
OMEGA MEDICAL IMAGING, INC. 675 HICKMAN CIRCLE Sanford,  FL  32771
Product CodeJAA  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-14
Decision Date1997-05-14
Summary:summary

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