FDA 510(k) Application Details - K982710

Device Classification Name Automated External Defibrillators (Non-Wearable)

  More FDA Info for this Device
510(K) Number K982710
Device Name Automated External Defibrillators (Non-Wearable)
Applicant CARDIAC SCIENCE, INC.
1176 MAIN STREET, BLDG. C
IRVINE, CA 92614 US
Other 510(k) Applications for this Company
Contact STAN E TILLMAN
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 08/04/1998
Decision Date 08/10/1998
Decision ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Special
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact