FDA 510(k) Application Details - K172196

Device Classification Name	Plethysmograph, Impedance   More FDA Info for this Device
510(K) Number	K172196
Device Name	Plethysmograph, Impedance
Applicant	ECOM Medical, Inc 27127 Calle Arroyo, Suite 1905 San Juan Capistrano, CA 92675 US Other 510(k) Applications for this Company
Contact	Guy Lowery 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	07/21/2017
Decision Date	09/19/2017
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