FDA 510(k) Application Details - K982279

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K982279
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	BCI INTL., INC. W238 N1650 ROCKWOOD DR. WAUKESHA, WI 53188 US Other 510(k) Applications for this Company
Contact	DONALD J ALEXANDER 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	06/30/1998
Decision Date	09/25/1998
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