510(k) K012226

MONITORING SYSTEM,MODEL ARGUS PB-1000 by Schiller AG — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2002
Date Received
July 16, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type