FDA 510(k) Application Details - K002445

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K002445
Device Name	Automated External Defibrillators (Non-Wearable)
Applicant	MEDTRONIC PHYSIO-CONTROL CORP. 11811 WILLOWS RD., N.E. REDMOND, WA 98073 US Other 510(k) Applications for this Company
Contact	BOB ZITO 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	08/09/2000
Decision Date	01/31/2001
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review