FDA 510(k) Application Details - K014157

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K014157
Device Name	Automated External Defibrillators (Non-Wearable)
Applicant	PHILIPS MEDICAL SYSTEMS 2401 FOURTH AVE., SUITE 500 SEATTLE, WA 98121 US Other 510(k) Applications for this Company
Contact	TAMARA YOUNT 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	12/19/2001
Decision Date	01/17/2002
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