FDA 510(k) Application Details - K053263

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K053263
Device Name	Detector And Alarm, Arrhythmia
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	870.1025   More FDA Info for this Regulation Number
Classification Product Code	DSI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2005
Decision Date	04/25/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review