FDA 510(k) Application Details - K040904

Device Classification Name	Over-The-Counter Automated External Defibrillator   More FDA Info for this Device
510(K) Number	K040904
Device Name	Over-The-Counter Automated External Defibrillator
Applicant	PHILIPS MEDICAL SYSTEMS 2301 5TH AVENUE, SUITE 200 SEATTLE, WA 98121-1825 US Other 510(k) Applications for this Company
Contact	TERESA SKARR Other 510(k) Applications for this Contact
Regulation Number	870.5310   More FDA Info for this Regulation Number
Classification Product Code	NSA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/2004
Decision Date	09/16/2004
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