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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Phonocardiograph
510(k) Number K864429
Device Name DSP100 CAROTID PHONOANGIOGRAPHY MODULE
Applicant
Intl. Acoustics, Inc.
1250 W. Northwest Hwy.,
Suite 720
Palatine,  IL  60067
Applicant Contact KIEN, PHD
Correspondent
Intl. Acoustics, Inc.
1250 W. Northwest Hwy.,
Suite 720
Palatine,  IL  60067
Correspondent Contact KIEN, PHD
Regulation Number870.2390
Classification Product Code
DQC  
Date Received11/12/1986
Decision Date 05/12/1987
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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