FDA 510(k) Application Details - K152911

Device Classification Name	Monitor, Breathing Frequency   More FDA Info for this Device
510(K) Number	K152911
Device Name	Monitor, Breathing Frequency
Applicant	EarlySense Ltd. 12 Tzvi Street Ramat Gan 5250429 IL Other 510(k) Applications for this Company
Contact	Dalia Argaman Other 510(k) Applications for this Contact
Regulation Number	868.2375   More FDA Info for this Regulation Number
Classification Product Code	BZQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/02/2015
Decision Date	05/06/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review