Oticon, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
68
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K133308TINNITUS SOUNDSUPPORTMarch 18, 2014
K973885OTICON DIGISOUND ITENovember 4, 1997
K973886OTICON DIGISOUND COMPACTNovember 4, 1997
K964683DIGIFOCUS ITEDecember 12, 1996
K963788PRIMOFOCUS COMPACTNovember 27, 1996
K961059DIGIFOCUS COMPACTMay 7, 1996
K960284OTICON /PRIMOFOCUS (PF)March 7, 1996
K954794OTICONNovember 13, 1995
K951002AMENDMENTS TO MULTIFOCUSSeptember 18, 1995
K950381OTICON/LOGICFebruary 27, 1995
K946045OTICONJanuary 30, 1995
K933307MULTIFOCUS COMPACT BTE HEARING AIDAugust 23, 1993
K932670OTICON MFAugust 5, 1993
K923388BTE HEARING AID OTICON MODEL: MULTIFOCUS POWERAugust 6, 1992
K923490BTE HEARING AID PERSONIC 410August 6, 1992
K923491BTE HEARING AID PERSONIC 425August 6, 1992
K905555A-ZILICONEJuly 6, 1992
K904673OTICAON BTE MODEL E34PNovember 1, 1990
K902559CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: PJuly 9, 1990
K902353CUSTOM ITE HEARING AID MODELS F AND LJune 14, 1990