FDA 510(k) Application Details - K082090

Device Classification Name Automated External Defibrillators (Non-Wearable)

  More FDA Info for this Device
510(K) Number K082090
Device Name Automated External Defibrillators (Non-Wearable)
Applicant CARDIAC SCIENCE CORPORATION
3303 MONTE VILLA PKWY.
BOTHELL, WA 98021 US
Other 510(k) Applications for this Company
Contact BEVERLY MAGRANE
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 07/24/2008
Decision Date 12/12/2008
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