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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 K891386
Device Name CVIS ULTRA-SCAN ONE IMAGING SYSTEM
Applicant
Cardiovascular Imaging Systems, Inc.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Applicant Contact CHIP JENNINGS
Correspondent
Cardiovascular Imaging Systems, Inc.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Correspondent Contact CHIP JENNINGS
Regulation Number892.1560
Classification Product Code
IYO  
Date Received03/09/1989
Decision Date 05/16/1989
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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