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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 K990066
Device Name CCD CAMERA, MODEL 9000
Applicant
Camtronics, Ltd.
Medical Systems
900 Walnut Ridge Dr., Box 950
Hartland,  WI  53029
Applicant Contact ROBERT KRIEDERMANN
Correspondent
Camtronics, Ltd.
Medical Systems
900 Walnut Ridge Dr., Box 950
Hartland,  WI  53029
Correspondent Contact ROBERT KRIEDERMANN
Regulation Number892.2030
Classification Product Code
LMA  
Date Received01/08/1999
Decision Date 03/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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