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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Radiographic-Film, Automatic
510(k) Number K940112
Device Name X-RAY FILM PROCESSOR
Applicant
Fischer Industries, Inc.
2630 Kaneville Ct.
Geneva,  IL  60134
Applicant Contact JOHN AMBROSE
Correspondent
Fischer Industries, Inc.
2630 Kaneville Ct.
Geneva,  IL  60134
Correspondent Contact JOHN AMBROSE
Regulation Number892.1900
Classification Product Code
IXW  
Date Received01/10/1994
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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