FDA 510(k) Application Details - K081828

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K081828
Device Name	Automated External Defibrillators (Non-Wearable)
Applicant	ZOLL MEDICAL CORPORATION 269 MILL ROAD CHELMSFORD, MA 01824-4105 US Other 510(k) Applications for this Company
Contact	EILEEN M BOYLE 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	06/27/2008
Decision Date	12/09/2008
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