FDA 510(k) Application Details - K082626

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K082626
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	WIRELESS 2000 RF & UWB TECHNOLOGIES LTD. 2421 ALPHA AVE BURNABY, BC V5C5L2 CA Other 510(k) Applications for this Company
Contact	EFRAIM GAVRILOVICH Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	DRT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2008
Decision Date	01/16/2009
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