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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
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