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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 K760464
Device Name PHON/STRESS SYSTEM (#21126A)
Applicant
HEWLETT-PACKARD CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HEWLETT-PACKARD CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.2390
Classification Product Code
DQC  
Date Received08/18/1976
Decision Date 08/30/1976
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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