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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K983945
Device Name CORTEX DERMASCAN C ULTRASONIC SYSTEM
Applicant
Cortex Technology Aps
Smedevaenget 10
Hadsund,  DK 9560
Applicant Contact GEORGE MYERS
Correspondent
Cortex Technology Aps
Smedevaenget 10
Hadsund,  DK 9560
Correspondent Contact GEORGE MYERS
Regulation Number892.1560
Classification Product Code
IYO  
Date Received11/05/1998
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
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