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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 K902185
Device Name DYNAMIC SPECTRAL PHONOCARDIOGRAPH
Applicant
Reeves Scientific, Inc.
65 Nash St.
New Haven,  CT  06511
Applicant Contact WILLIAM REEVES
Correspondent
Reeves Scientific, Inc.
65 Nash St.
New Haven,  CT  06511
Correspondent Contact WILLIAM REEVES
Regulation Number870.2390
Classification Product Code
DQC  
Date Received05/14/1990
Decision Date 03/25/1991
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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