EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM

Device Classification Name

computer, diagnostic, programmable

510(k) Number K071348
Device Name EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM
Applicant
MENNEN MEDICAL LTD.
4 ha-yarden st.
p.o. box 102
yavne, rehovot, 

IL

76100

Applicant Contact micha oestereich
Correspondent
MENNEN MEDICAL LTD.
4 ha-yarden st.
p.o. box 102
yavne, rehovot, 

IL

76100

Correspodent Contact micha oestereich
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 05/14/2007
Decision Date 09/07/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No