510(k) K031760

VIEWPOINT TELEMETRY SYSTEM by Datascope Corp. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2003
Date Received
June 6, 2003
Clearance Type
Abbreviated
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