FDA 510(k) Application Details - K083828

Device Classification Name	Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)   More FDA Info for this Device
510(K) Number	K083828
Device Name	Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)
Applicant	TRANSOMA 119 14TH STREET NW ST. PAUL, MN 55112 US Other 510(k) Applications for this Company
Contact	LISA STONE 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	12/23/2008
Decision Date	02/11/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review