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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 K141441
Device Name MENNTOR X7
Applicant
MENNEN MEDICAL LTD.
4 ha-yarden st. yavne 8122804
p.o. box 102 rehovot 7610002
yavne,  IL 8122804
Applicant Contact ifat shwarts
Correspondent
MENNEN MEDICAL LTD.
4 ha-yarden st. yavne 8122804
p.o. box 102 rehovot 7610002
yavne,  IL 8122804
Correspondent Contact ifat shwarts
Regulation Number870.1025
Classification Product Code
DSI  
Date Received06/02/2014
Decision Date 01/09/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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