510(k) K113187

AVIVO MOBILE PATIENT MANAGEMENT by Corventis, Inc. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2012
Date Received
October 31, 2011
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