FDA 510(k) Application Details - K970445

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K970445
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	PACE TECH MEDICAL MONITORS, INC. 510 GARDEN AVE. NORTH CLEARWATER, FL 34615-4126 US Other 510(k) Applications for this Company
Contact	IIHAN M BILGUTAY 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	02/05/1997
Decision Date	01/30/1998
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