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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K864278
Device Name DS-II DIGITAL SONOGRAPHY SYSTEM
Applicant
Intl. Acoustics, Inc.
1250 W. Northwest Hwy.,
Suite 720
Palatine,  IL  60067
Applicant Contact GERALD KIEN
Correspondent
Intl. Acoustics, Inc.
1250 W. Northwest Hwy.,
Suite 720
Palatine,  IL  60067
Correspondent Contact GERALD KIEN
Regulation Number870.1875
Classification Product Code
DQD  
Date Received10/30/1986
Decision Date 06/10/1987
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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