Medical Device Manufacturer · US , Crofton , MD

Otodynamics, Ltd.

7 submissions · 7 cleared · Since 1997
7
Total
7
Cleared
0
Denied

Otodynamics, Ltd. — FDA 510(k) Submissions

Otodynamics, Ltd. has submitted 7 FDA 510(k) premarket notifications since 1997, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Audiometer . Use the specialty filter in the sidebar to narrow results.

7 devices
1–7 of 7
Otoport Pro
K240430 · EWO Audiometer · Ear, Nose, Throat
Mar 2024 30d
Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit
K143395 · EWO Audiometer · Ear, Nose, Throat
Feb 2015 89d
OTODYNAMICS OTOPORT
K072033 · EWO Audiometer · Ear, Nose, Throat
Nov 2007 112d
ILO292 DP ECHOPORT PLUS OAE SYSTEM
K983350 · EWO Audiometer · Ear, Nose, Throat
Dec 1998 79d
ILO292 DP ECHOPORT PLUS OAE SYSTEM
K983351 · EWO Audiometer · Ear, Nose, Throat
Dec 1998 79d
ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK
K983352 · EWO Audiometer · Ear, Nose, Throat
Dec 1998 79d
ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC
K962995 · EWO Audiometer · Ear, Nose, Throat
Jan 1997 162d
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