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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Air, Medical Recirculating
510(k) Number K851094
Device Name MODEL BION 1/TYPE 1084T CAR IONIZER
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 Number880.5045
Classification Product Code
FRF  
Date Received03/19/1985
Decision Date 06/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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