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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 K894370
Device Name GENESIS III, (MOD. 7003/7004)
Applicant
Biosound, Inc.
7990 Castleway Dr.
P.O. Box 50867
Indianapolis,  IN  46250
Applicant Contact ROBERT COURTNEY
Correspondent
Biosound, Inc.
7990 Castleway Dr.
P.O. Box 50867
Indianapolis,  IN  46250
Correspondent Contact ROBERT COURTNEY
Regulation Number870.2330
Classification Product Code
DXK  
Date Received07/14/1989
Decision Date 01/29/1990
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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