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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 K913209
Device Name ACCESSORY TO GENESIS III (GCFM)
Applicant
Biosound, Inc.
7990 Castleway Dr.
P.O. Box 50867
Indianapolis,  IN  46250
Applicant Contact WILLIAM E MCKAY
Correspondent
Biosound, Inc.
7990 Castleway Dr.
P.O. Box 50867
Indianapolis,  IN  46250
Correspondent Contact WILLIAM E MCKAY
Regulation Number870.2330
Classification Product Code
DXK  
Date Received07/19/1991
Decision Date 05/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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