FDA 510(k) Application Details - K122253

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

  More FDA Info for this Device
510(K) Number K122253
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant GE MEDICAL SYSTEMS CHINA CO., LTD.
8200 WEST TOWER AVE
MILWAUKEE, WI 53223 US
Other 510(k) Applications for this Company
Contact ROBERT CASARSA
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 07/27/2012
Decision Date 03/22/2013
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