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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 K861994
Device Name MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM
Applicant
Medicor USA , Ltd.
1400 Holly Ave.
Columbus,  OH  43212
Applicant Contact GEZA PATAKY
Correspondent
Medicor USA , Ltd.
1400 Holly Ave.
Columbus,  OH  43212
Correspondent Contact GEZA PATAKY
Regulation Number892.1680
Classification Product Code
KPR  
Date Received05/23/1986
Decision Date 07/18/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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