FDA 510(k) Application Details - K010634

Device Classification Name Automated External Defibrillators (Non-Wearable)

  More FDA Info for this Device
510(K) Number K010634
Device Name Automated External Defibrillators (Non-Wearable)
Applicant AGILENT TECHNOLOGIES, INC.
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1099 US
Other 510(k) Applications for this Company
Contact RICHARD J PETERSEN
Other 510(k) Applications for this Contact
Regulation Number 870.5310

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

  More FDA Info for this Product Code
Date Received 03/02/2001
Decision Date 06/11/2001
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