FDA 510(k) Application Details - K141441

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K141441
Device Name	Detector And Alarm, Arrhythmia
Applicant	MENNEN MEDICAL LTD. 4 HA-YARDEN ST. YAVNE 8122804 P.O. BOX 102 REHOVOT 7610002 YAVNE 8122804 IL Other 510(k) Applications for this Company
Contact	IFAT SHWARTS Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	DSI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2014
Decision Date	01/09/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review