FDA 510(k) Application Details - K063222

Device Classification Name	More FDA Info for this Device
510(K) Number	K063222
Device Name	CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004
Applicant	CARDIONET, INC 1010 2ND AVE., SUITE 700 SAN DIEGO, CA 92101 US Other 510(k) Applications for this Company
Contact	JACK GAIKWAD Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/24/2006
Decision Date	11/14/2006
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