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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 K052283
Device Name HEART STG SYSTEM AND SOFTWARE
Applicant
Stethographics, Inc.
1153 Centre St.
Boston,  MA  02130
Applicant Contact ROZANNE PACIEJ
Correspondent
Stethographics, Inc.
1153 Centre St.
Boston,  MA  02130
Correspondent Contact ROZANNE PACIEJ
Regulation Number870.1875
Classification Product Code
DQD  
Date Received08/22/2005
Decision Date 12/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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