Medical Device Manufacturer · US , Somerset , NJ

Oticon, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1993
9
Total
9
Cleared
0
Denied

FDA 510(k) Regulatory Record - Oticon, Inc. Ear, Nose, Throat ✕

9 devices
1-9 of 9
Cleared Nov 04, 1997
OTICON DIGISOUND ITE
K973885 · ESD
Ear, Nose, Throat · 21d
Cleared Nov 04, 1997
OTICON DIGISOUND COMPACT
K973886 · ESD
Ear, Nose, Throat · 21d
Cleared Dec 12, 1996
DIGIFOCUS ITE
K964683 · ESD
Ear, Nose, Throat · 20d
Cleared May 07, 1996
DIGIFOCUS COMPACT
K961059 · ESD
Ear, Nose, Throat · 50d
Cleared Mar 07, 1996
OTICON /PRIMOFOCUS (PF)
K960284 · ESD
Ear, Nose, Throat · 48d
Cleared Nov 13, 1995
OTICON
K954794 · ESD
Ear, Nose, Throat · 26d
Cleared Feb 27, 1995
OTICON/LOGIC
K950381 · ESD
Ear, Nose, Throat · 27d
Cleared Jan 30, 1995
OTICON
K946045 · ESD
Ear, Nose, Throat · 49d
Cleared Aug 23, 1993
MULTIFOCUS COMPACT BTE HEARING AID
K933307 · ESD
Ear, Nose, Throat · 47d
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