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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K070515
Device Name A-VIEW BASIC AND PLUS
Applicant
Cordatec N.V.
1467 Vigilante Ave.
Bailey,  CO  80421
Applicant Contact BARBARA DEBIASE
Correspondent
Cordatec N.V.
1467 Vigilante Ave.
Bailey,  CO  80421
Correspondent Contact BARBARA DEBIASE
Regulation Number892.1570
Classification Product Code
ITX  
Date Received02/22/2007
Decision Date 07/30/2007
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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