FDA 510(k) Application Details - K023713

Device Classification Name	Tester, Electrode, Surface, Electrocardiographic   More FDA Info for this Device
510(K) Number	K023713
Device Name	Tester, Electrode, Surface, Electrocardiographic
Applicant	SONTRA MEDICAL INC. 58 CHARLES ST. CAMBRIDGE, MA 02141 US Other 510(k) Applications for this Company
Contact	ALBERT FARINHA Other 510(k) Applications for this Contact
Regulation Number	870.2370   More FDA Info for this Regulation Number
Classification Product Code	KRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/2002
Decision Date	01/28/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review