SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000


Device Classification Name

tester, electrode, surface, electrocardiographic

510(k) Number K023713
Device Name SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000
Original Applicant
SONTRA MEDICAL INC.
58 charles st.
cambridge, 
MA 
02141

Original Contact albert farinha
Regulation Number 870.2370
Classification Product Code
KRC  
Date Received 11/04/2002
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