FDA 510(k) Application Details - K031376

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

  More FDA Info for this Device
510(K) Number K031376
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
4502 WOODLAND CORP.BLVD.
TAMPA, FL 33614 US
Other 510(k) Applications for this Company
Contact MELISSA ROBINSON
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 05/01/2003
Decision Date 07/16/2003
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