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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K890970
Device Name TRUVEL TZ-3X X-RAY DIGITIZING SCANNER
Applicant
Truvel Corp.
8943 Fullbright Ave.
Chatsworth,  CA  91311
Applicant Contact ALBERT J KOUBA
Correspondent
Truvel Corp.
8943 Fullbright Ave.
Chatsworth,  CA  91311
Correspondent Contact ALBERT J KOUBA
Regulation Number892.2030
Classification Product Code
LMA  
Date Received02/27/1989
Decision Date 05/11/1989
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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