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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 K870545
Device Name ANDRIES PHYSICAL ASSESSMENT COMPUTER
Applicant
Andries Tek, Inc.
8868 Research Blvd.
Bldg. 202
Austin,  TX  78758
Applicant Contact FRANCIS ANDRIES
Correspondent
Andries Tek, Inc.
8868 Research Blvd.
Bldg. 202
Austin,  TX  78758
Correspondent Contact FRANCIS ANDRIES
Regulation Number870.2390
Classification Product Code
DQC  
Date Received02/10/1987
Decision Date 08/14/1987
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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