FDA 510(k) Application Details - K922668

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K922668
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	COLIN MEDICAL INSTRUMENTS CORP. 5850 FARINON DR. SAN ANTONIO, TX 78249 US Other 510(k) Applications for this Company
Contact	SUSAN D GOLSTEIN-FA 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	06/04/1992
Decision Date	01/29/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review