510(k) K023713

SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 by Sontra Medical, Inc. — Product Code KRC

K023713 is an FDA 510(k) premarket notification submitted by Sontra Medical, Inc. for the device "SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000". The FDA issued a decision of Substantially Equivalent on January 28, 2004. The device falls under product code KRC (Tester, Electrode, Surface, Electrocardiographic), a Class II device regulated under 21 CFR 870.2370. Sontra Medical, Inc. has at least 1 other 510(k) clearance on record.