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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cart, Emergency, Cardiopulmonary (Excluding Equipment)
510(k) Number K850761
Device Name MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C
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 Number868.6175
Classification Product Code
BZN  
Date Received02/25/1985
Decision Date 09/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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