FDA 510(k) Application Details - K153135

Device Classification Name	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K153135
Device Name	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant	GUANGDONG BIOLIGHT MEDITECH CO., LTD. INNOVATION FIRST ROAD TECHNOLOGY INNOVATION COAST ZHUHAI 519085 CN Other 510(k) Applications for this Company
Contact	Jin Liang 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	10/30/2015
Decision Date	02/25/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review