FDA 510(k) Application Details - K123472

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K123472
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	THERAPEUTIC MONITORING SYSTEMS (TMS), INC. 1193 SHERMAN ST ALAMEDA, CA 94501 US Other 510(k) Applications for this Company
Contact	CRAIG J COOMBS Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	MHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2012
Decision Date	03/05/2013
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