FDA 510(k) Application Details - K152902

Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

  More FDA Info for this Device
510(K) Number K152902
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
MINDRAY BUILDING, KEJI 12TH ROAD SOUTH,
HIGH-TECH INDUSTRIAL PARK, NANSHAN
SHENZHEN 518057 CN
Other 510(k) Applications for this Company
Contact YANHONG BAI
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 10/01/2015
Decision Date 02/18/2016
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact