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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Beam Limiting, X-Ray, Diagnostic
510(k) Number K093596
Device Name LUMOS, MODEL R 72B
Applicant
Lumos, Inc.
8726 Ferrara Ct.
Naples,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
Lumos, Inc.
8726 Ferrara Ct.
Naples,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number892.1610
Classification Product Code
KPW  
Date Received11/20/2009
Decision Date 01/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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