VITALOGIK MODEL 4000/4500


Device Classification Name

detector and alarm, arrhythmia

510(k) Number K073140
Device Name VITALOGIK MODEL 4000/4500
Applicant
MENNEN MEDICAL LTD.
4 hayarden st., yavne
p.o.box 102
rehovot, 

IL

76100

Applicant Contact ifat oren
Correspondent
MENNEN MEDICAL LTD.
4 hayarden st., yavne
p.o.box 102
rehovot, 

IL

76100

Correspodent Contact ifat oren
Regulation Number 870.1025
Classification Product Code
DSI  
Date Received 11/07/2007
Decision Date 11/21/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No