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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K912448
Device Name CSP
Applicant
Fischer Imaging Corp.
12300 N. Grant St.
Denver,  CO  80241
Applicant Contact THOMAS H GALLINGER
Correspondent
Fischer Imaging Corp.
12300 N. Grant St.
Denver,  CO  80241
Correspondent Contact THOMAS H GALLINGER
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received06/03/1991
Decision Date 08/28/1991
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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