FDA 510(k) Application Details - K123048

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K123048
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	ADVANCED INSTRUMENTATIONS, INC. 601 WEST 20TH STREET HIALEAH, FL 33010 US Other 510(k) Applications for this Company
Contact	JORGE MILLAN 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	09/28/2012
Decision Date	01/11/2013
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