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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K141885
Device Name CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY
Applicant
Minxray, Inc.
8870 Ravello Court
Naples,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
Minxray, Inc.
8870 Ravello Court
Naples,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number892.1720
Classification Product Code
IZL  
Subsequent Product Codes
LLZ   MQB  
Date Received07/11/2014
Decision Date 09/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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