510(k) K002604

CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM by Invivo Research, Inc. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2002
Date Received
August 22, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type