FDA 510(k) Application Details - K180479

Device Classification Name	Plethysmograph, Impedance   More FDA Info for this Device
510(K) Number	K180479
Device Name	Plethysmograph, Impedance
Applicant	Sensible Medical Innovations Ltd. 6 Meir Areil St. Netanya, POB 8702 4059300 IL Other 510(k) Applications for this Company
Contact	Inbal Ben-Tzvi Other 510(k) Applications for this Contact
Regulation Number	870.2770   More FDA Info for this Regulation Number
Classification Product Code	DSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/22/2018
Decision Date	02/28/2019
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