Medical Device Manufacturer · US , Mchenry , IL

Grason-Stadler, Inc.

16 submissions · 16 cleared · Since 1979
16
Total
16
Cleared
0
Denied

Grason-Stadler, Inc. — FDA 510(k) Submissions

Grason-Stadler, Inc. has submitted 16 FDA 510(k) premarket notifications since 1979, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Audiometer, Tester, Auditory Impedance, Stimulator, Auditory, Evoked Response, Calibrator, Hearing Aid / Earphone And Analysis Systems . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
GSI Corti
K180287 · EWO Audiometer · Ear, Nose, Throat
May 2018 99d
GSI Novus
K172403 · EWO Audiometer · Ear, Nose, Throat
Oct 2017 72d
GSI 2000 MIDDLE EAR ANALYZER
K000097 · ETY Tester, Auditory Impedance · Ear, Nose, Throat
Apr 2000 90d
GSI 70 AUDIOPATH SCREENER
K974237 · EWO Audiometer · Ear, Nose, Throat
Feb 1998 90d
GSI SA60 DPOAE SYSTEM
K970324 · ETW Calibrator, Hearing Aid /... · Ear, Nose, Throat
Jun 1997 130d
GSI 61 CLINICAL AUDIOMETER
K953684 · EWO Audiometer · Ear, Nose, Throat
Oct 1995 85d
GSI 65 COMPUTERIZED AUDIOMETER
K951759 · EWO Audiometer · Ear, Nose, Throat
Jul 1995 80d
GSI 17 SCREENING AUDIOMETER
K902540 · EWO Audiometer · Ear, Nose, Throat
Jul 1990 37d
ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER
K890124 · EWO Audiometer · Ear, Nose, Throat
Jul 1989 184d
THE SCREENER GSI 55 ABR SCREENER
K870030 · GWJ Stimulator, Auditory,... · Neurology
Mar 1987 67d
MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)
K863353 · ETY Tester, Auditory Impedance · Ear, Nose, Throat
Nov 1986 66d
AUDIOMETER
K843618 · EWO Audiometer · Ear, Nose, Throat
Dec 1984 80d
MIDDLE EAR ANALYZER (IMPEDANCE AUDIO
K820715 · EWO Audiometer · Ear, Nose, Throat
Apr 1982 25d
AUDIOMETER
K810583 · EWO Audiometer · Ear, Nose, Throat
Apr 1981 57d
MIDDLE EAR ANALYZER (IMPED. AUDIOMTR)
K790846 · EWO Audiometer · Ear, Nose, Throat
May 1979 13d
AUDIOMETER
K790609 · EWO Audiometer · Ear, Nose, Throat
Apr 1979 12d
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