FDA 510(k) Application Details - K022929

Device Classification Name Automated External Defibrillators (Non-Wearable)

  More FDA Info for this Device
510(K) Number K022929
Device Name Automated External Defibrillators (Non-Wearable)
Applicant CARDIAC SCIENCE, INC.
16931 MILLIKAN AVE.
IRVINE, CA 92606 US
Other 510(k) Applications for this Company
Contact JOHN CARLINE
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 09/04/2002
Decision Date 01/27/2003
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