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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 K921750
Device Name CVIS INSIGHT III SYSTEM
Applicant
Cardiovascular Imaging Systems, Inc.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Applicant Contact STAN E TILLMAN
Correspondent
Cardiovascular Imaging Systems, Inc.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Correspondent Contact STAN E TILLMAN
Regulation Number892.1570
Classification Product Code
ITX  
Date Received04/13/1992
Decision Date 07/13/1992
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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