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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 K902926
Device Name COLOR VELOCITY IMAGING (CVI) OPTION FOR PLATINUM
Applicant
Philips Medical Systems North America, Inc.
2722 S. Fairview St.
Santa Ana,  CA  92704
Applicant Contact GLADYS D MAY
Correspondent
Philips Medical Systems North America, Inc.
2722 S. Fairview St.
Santa Ana,  CA  92704
Correspondent Contact GLADYS D MAY
Regulation Number892.1570
Classification Product Code
ITX  
Date Received07/03/1990
Decision Date 11/26/1990
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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