CARDIOSEN’C


Device Classification Name

transmitters and receivers, electrocardiograph, telephone

510(k) Number K080047
Device Name CARDIOSEN’C
Applicant
SHL TELEMEDICINE INTERNATIONAL LTD.
31 haavoda st.
binyamina, 

IL

30500

Applicant Contact yoram levy
Correspondent
SHL TELEMEDICINE INTERNATIONAL LTD.
31 haavoda st.
binyamina, 

IL

30500

Correspodent Contact yoram levy
Regulation Number 870.2920
Classification Product Code
DXH  
Date Received 01/08/2008
Decision Date 07/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No