CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER


Device Classification Name

stethoscope, electronic

510(k) Number K023759
Device Name CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER
Original Applicant
SONOMEDICA
8230 leesburg pike
suite 500
vienna, 
VA 
22182

Original Contact sailor mohler
Regulation Number 870.1875
Classification Product Code
DQD  
Subsequent Product Code
DQC  
Date Received 11/08/2002
Decision Date 05/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No