FDA 510(k) Application Details - K012274

Device Classification Name	Dc-Defibrillator, Low-Energy, (Including Paddles)   More FDA Info for this Device
510(K) Number	K012274
Device Name	Dc-Defibrillator, Low-Energy, (Including Paddles)
Applicant	MEDTRONIC PHYSIO-CONTROL CORP. 11811 WILLOWS RD NE P.O. BOX 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	870.5300   More FDA Info for this Regulation Number
Classification Product Code	LDD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/2001
Decision Date	02/05/2002
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