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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, Fluoroscopic, Image-Intensified
510(k) Number K950971
Device Name MOBIL C-ARM, REGURBISHED, VARIOUS MODELS
Applicant
Pro-Tronics, Inc.
106 Industrial Dr.
Gilberts,  IL  60136
Applicant Contact CURT BORK
Correspondent
Pro-Tronics, Inc.
106 Industrial Dr.
Gilberts,  IL  60136
Correspondent Contact CURT BORK
Regulation Number892.1650
Classification Product Code
JAA  
Date Received02/21/1995
Decision Date 04/11/1995
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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