FDA 510(k) Application Details - K172431

Device Classification Name	Plethysmograph, Impedance   More FDA Info for this Device
510(K) Number	K172431
Device Name	Plethysmograph, Impedance
Applicant	PhysioWave, Inc. 1700 Wyatt Drive Suite 2 Santa Clara, CA 95054 US Other 510(k) Applications for this Company
Contact	Laurent Giovangrandi 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	08/11/2017
Decision Date	03/14/2018
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