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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echocardiograph
510(k) Number K904978
Device Name SOFTWARE PROGRAM USED W/PRISM PRODUCTS
Applicant
Prism Imaging, Inc.
C/O Hyman, Phelps & Mcnamara
1120 G St., NW
Washington,  DC  20005
Applicant Contact ROBERT A DORMER
Correspondent
Prism Imaging, Inc.
C/O Hyman, Phelps & Mcnamara
1120 G St., NW
Washington,  DC  20005
Correspondent Contact ROBERT A DORMER
Regulation Number870.2330
Classification Product Code
DXK  
Date Received11/01/1990
Decision Date 02/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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