FDA 510(k) Application Details - K191697

Device Classification Name	Plethysmograph, Impedance   More FDA Info for this Device
510(K) Number	K191697
Device Name	Plethysmograph, Impedance
Applicant	Zynex Medical, Inc. 9995 Maroon Circle Englewood, CO 80112 US Other 510(k) Applications for this Company
Contact	Thomas Sandgaard 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	06/25/2019
Decision Date	02/21/2020
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