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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K130658
Device Name ELIXBO PM545
Applicant
XBO MEDICAL SYSTEMS CO., LTD
INDUSTRIAL PK, RARE EARTH HI-TECH ZONE,
BAOTOU, INNER
MONGOLIA,  CN 014030
Applicant Contact JINHONG GUO
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/12/2013
Decision Date 07/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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