FDA 510(k) Application Details - K131763

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

  More FDA Info for this Device
510(K) Number K131763
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant GUANGDONG BIOLIGHT MEDITECH CO., LTD.
P.O. BOX 120-119
SHANGHAI 200120 CN
Other 510(k) Applications for this Company
Contact Diana Hong
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 06/17/2013
Decision Date 07/15/2013
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



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