Medical Device Manufacturer · US , Tulsa , OK

Trutone - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1997

Recent clearances: SIBELMED AC50D, AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC, AUDIFON H20 PC/AUDIFON H32 PP

5
Total
5
Cleared
0
Denied

FDA 510(k) Regulatory Record - Trutone Ear, Nose, Throat ✕

5 devices
1-5 of 5
Cleared Mar 10, 1998
SIBELMED AC50D
K973377 · EWO
Ear, Nose, Throat · 183d
Cleared Jul 31, 1997
AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC
K972550 · ESD
Ear, Nose, Throat · 31d
Cleared Jul 30, 1997
AUDIFON H20 PC/AUDIFON H32 PP
K972552 · ESD
Ear, Nose, Throat · 30d
Cleared Jul 23, 1997
JAZZ PP AGC-O, JAZZ PP
K972542 · ESD
Ear, Nose, Throat · 14d
Cleared Jul 23, 1997
TWIST PPAGC-1, TWIST PP
K972543 · ESD
Ear, Nose, Throat · 14d
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