FDA 510(k) Application Details - K153021

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K153021
Device Name	Oximeter
Applicant	AMEMO INC 1154 CADILLAC COURT MILPITAS, CA 95035 US Other 510(k) Applications for this Company
Contact	HUA XIE Other 510(k) Applications for this Contact
Regulation Number	870.2700   More FDA Info for this Regulation Number
Classification Product Code	DQA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2015
Decision Date	11/22/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review