LUMOS, MODEL R 72B

Device, Beam Limiting, X-ray, Diagnostic

LUMOS, INC

The following data is part of a premarket notification filed by Lumos, Inc with the FDA for Lumos, Model R 72b.

Pre-market Notification Details

Device IDK093596
510k NumberK093596
Device Name:LUMOS, MODEL R 72B
ClassificationDevice, Beam Limiting, X-ray, Diagnostic
Applicant LUMOS, INC 8726 FERRARA CT Naples,  FL  34114
ContactDaniel Kamm
CorrespondentDaniel Kamm
LUMOS, INC 8726 FERRARA CT Naples,  FL  34114
Product CodeKPW  
CFR Regulation Number892.1610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-20
Decision Date2010-01-12
Summary:summary

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