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Sophono, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K153391Sophono Bone Conduction Systems (S) Configuration and (M) ConfigurationJune 16, 2016
K132189OTOMAG BONE CONDUCATION HEARING SYSTEMNovember 22, 2013
K123962OTOMAG BONE CONDUCTION HEARING SYSTEMApril 8, 2013
K102199OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)May 23, 2011
K100193OTOMAG BONE CONDUCTION HEARING SYSTEMMay 18, 2010