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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K933447
Device Name STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM
Applicant
GE Medical Systems
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact LARRY A KROGER
Correspondent
GE Medical Systems
P.O. Box 7550
Madison,  WI  53707
Correspondent Contact Monica Morrison
Regulation Number892.1650
Classification Product Code
OXO  
Date Received07/13/1993
Decision Date 08/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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