Topera, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K151245Rhythm View Workstation (non-streaming, steaming option)September 15, 2015
K142901RhythmView WorkstationDecember 19, 2014
K142182FRIMAP ADAPTER CONNECTOR (MAC)September 9, 2014
K133305RHYTHM VIEW WORKSTATIONDecember 16, 2013
K130827FIRMAP CATHETEROctober 31, 2013
K123295RHYTHM VIEWApril 24, 2013
K110878RHYTHMVIEW (TM)September 23, 2011