FDA 510(k) Application Details - K011144

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K011144
Device Name	Automated External Defibrillators (Non-Wearable)
Applicant	MEDTRONIC PHYSIO-CONTROL CORP. 11811 WILLOWS RD NE BX 97006 REDMOND, WA 98073-9706 US Other 510(k) Applications for this Company
Contact	SHERRI L POCOCK 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	04/16/2001
Decision Date	12/03/2001
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