FDA 510(k) Application Details - K043517

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K043517
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	NIHON KOHDEN AMERICA, INC. 90 ICON ST. FOOTHILL RANCH, CA 92610-1601 US Other 510(k) Applications for this Company
Contact	SERRAH NAMINI 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	12/20/2004
Decision Date	02/03/2005
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