FDA 510(k) Application Details - K121722

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K121722
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	FLUKE BIOMEDICAL 6045 COCHRAN RD. SOLON, OH 44139 US Other 510(k) Applications for this Company
Contact	JOHN NELSON 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	06/12/2012
Decision Date	10/11/2012
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