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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K833484
Device Name COMPUTED TOMOGRAPHY ORIENTED ROTARY ARC
Applicant
A. Patil, M.D.
Trinity Professional Bldg.
Suite 404
Minot,  ND  58701
Applicant Contact A. PATIL, M.D.
Correspondent
A. Patil, M.D.
Trinity Professional Bldg.
Suite 404
Minot,  ND  58701
Correspondent Contact A. PATIL, M.D.
Regulation Number882.4560
Classification Product Code
HAW  
Date Received10/07/1983
Decision Date 12/29/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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