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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
PO BOX 414
MILWAUKEE,  WI  53201
Applicant Contact LARRY A KROGER
Correspondent
GE MEDICAL SYSTEMS
PO 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
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