FDA 510(k) Application Details - K100376

Device Classification Name	System,Network And Communication,Physiological Monitors   More FDA Info for this Device
510(K) Number	K100376
Device Name	System,Network And Communication,Physiological Monitors
Applicant	EARLYSENSE LTD. 12 TZVI STREET RAMAT GAN 52504 IL Other 510(k) Applications for this Company
Contact	DALIA ARGAMAN Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	MSX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2010
Decision Date	08/06/2010
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