FDA 510(k) Application Details - K092809

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K092809
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	WR MEDICAL ELECTRONICS CO. 800 LAVANGER LANE STOUGHTON, WI 53589 US Other 510(k) Applications for this Company
Contact	Gary Syring 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	09/11/2009
Decision Date	10/19/2010
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