FDA 510(k) Application Details - K152645

Device Classification Name	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K152645
Device Name	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant	DICTUM HEALTH, INC 255 3RD AVENUE, SUITE 102 OAKLAND, CA 94607 US Other 510(k) Applications for this Company
Contact	PAUL LANDESMAN Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	MWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/2015
Decision Date	02/09/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review