FDA 510(k) Application Details - K063035

Device Classification Name	Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)   More FDA Info for this Device
510(K) Number	K063035
Device Name	Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)
Applicant	TRANSNOMA MEDICAL, INC. 4358 WEST ROUND LAKE RD. ARDEN HILLS, MN 55112 US Other 510(k) Applications for this Company
Contact	ANGELA RAUN 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	09/29/2006
Decision Date	10/01/2007
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