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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Electrode, Surface, Electrocardiographic
510(k) Number K023713
Device Name SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000
Applicant
Sontra Medical, Inc.
58 Charles St.
Cambridge,  MA  02141
Applicant Contact ALBERT FARINHA
Correspondent
Sontra Medical, Inc.
58 Charles St.
Cambridge,  MA  02141
Correspondent Contact ALBERT FARINHA
Regulation Number870.2370
Classification Product Code
KRC  
Date Received11/04/2002
Decision Date 01/28/2004
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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