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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K922703
Device Name THE ACTA FORMULA
Applicant
Biosound, Inc.
7990 Castleway Dr.
P.O. Box 50867
Indianapolis,  IN  46250
Applicant Contact WAYNE L NETHERCUT
Correspondent
Biosound, Inc.
7990 Castleway Dr.
P.O. Box 50867
Indianapolis,  IN  46250
Correspondent Contact WAYNE L NETHERCUT
Regulation Number870.2340
Classification Product Code
DPS  
Date Received06/05/1992
Decision Date 04/27/1993
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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