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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 K934481
Device Name EP-X
Applicant
Fischer Imaging Corp.
12300 N. Grant St.
Denver,  CO  80241
Applicant Contact JAMES W MORGAN
Correspondent
Fischer Imaging Corp.
12300 N. Grant St.
Denver,  CO  80241
Correspondent Contact JAMES W MORGAN
Regulation Number892.1650
Classification Product Code
JAA  
Date Received09/14/1993
Decision Date 11/03/1993
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
Recalls CDRH Recalls
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