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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, Stationary
510(k) Number K202394
Device Name EOSedge
Applicant
Eos Imaging
10 Rue Mercoeur
Paris,  FR F-75011
Applicant Contact Bernard Ismael
Correspondent
Eos Imaging
10 Rue Mercoeur
Paris,  FR F-75011
Correspondent Contact Bernard Ismael
Regulation Number892.1680
Classification Product Code
KPR  
Date Received08/21/2020
Decision Date 09/16/2020
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
Recalls CDRH Recalls
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