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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K844997
Device Name IAI PROGRAM-COMPUTER PROGRAM
Applicant
Intl. Acoustics, Inc.
1250 W. Northwest Highway,
Suite 720
Palatine,  IL  60067
Applicant Contact GERALD A KIEN
Correspondent
Intl. Acoustics, Inc.
1250 W. Northwest Highway,
Suite 720
Palatine,  IL  60067
Correspondent Contact GERALD A KIEN
Regulation Number870.1435
Classification Product Code
DXG  
Date Received12/26/1984
Decision Date 04/09/1985
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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