FDA 510(k) Application Details - K171836

Device Classification Name	Monitor, Breathing Frequency   More FDA Info for this Device
510(K) Number	K171836
Device Name	Monitor, Breathing Frequency
Applicant	EarlySense Ltd. 7 Derech Zeev Jabotinsky Ramat Gan 5252007 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	06/20/2017
Decision Date	01/04/2018
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