FDA 510(k) Application Details - K003107

Device Classification Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

  More FDA Info for this Device
510(K) Number K003107
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant AGILENT TECHNOLOGIES, INC.
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1099 US
Other 510(k) Applications for this Company
Contact MIKE HUDON
Other 510(k) Applications for this Contact
Regulation Number 870.2300

  More FDA Info for this Regulation Number
Classification Product Code MWI
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 10/04/2000
Decision Date 10/19/2000
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