FDA 510(k) Application Details - K972242

Device Classification Name	Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)   More FDA Info for this Device
510(K) Number	K972242
Device Name	Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)
Applicant	MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE MINNEAPOLIS, MN 55432-3576 US Other 510(k) Applications for this Company
Contact	NORA K HADDING Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	MXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/1997
Decision Date	01/16/1998
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