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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Simulation, Radiation Therapy
510(k) Number K022219
Device Name EXOMIO, MODEL 1.1
Applicant
Medcom GmbH
Rundeturmstr. 12
Darmstadt, Hessen,  DE 64283
Applicant Contact IOANNIS NOMIKOS
Correspondent
Medcom GmbH
Rundeturmstr. 12
Darmstadt, Hessen,  DE 64283
Correspondent Contact IOANNIS NOMIKOS
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received07/09/2002
Decision Date 10/07/2002
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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