FDA 510(k) Application Details - K120727

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K120727
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	EDAN INSTRUMENTS INC 3/F-B, NANSHAN MEDICAL EQUIPMENTS PARK SHENZHEN 518067 CN Other 510(k) Applications for this Company
Contact	RANDY JIANG Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	MHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/09/2012
Decision Date	06/21/2013
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