510(k) K950536

PICIS CHART+ by Picis — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1995
Date Received
February 7, 1995
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