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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name detector and alarm, arrhythmia
510(k) Number K052288
Device Name VITALOGIK
Applicant
MENNEN MEDICAL LTD.
4 hayarden st.
yavne,  IL 81228
Applicant Contact micha oestereich
Correspondent
MENNEN MEDICAL LTD.
4 hayarden st.
yavne,  IL 81228
Correspondent Contact micha oestereich
Regulation Number870.1025
Classification Product Code
DSI  
Date Received08/23/2005
Decision Date 12/20/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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