Medical Device Manufacturer · US , Mchenry , IL

Frye Electronics, Inc.

13 submissions · 13 cleared · Since 1980
13
Total
13
Cleared
0
Denied

Frye Electronics, Inc. — FDA 510(k) Submissions

Frye Electronics, Inc. has submitted 13 FDA 510(k) premarket notifications since 1980, of which 13 received clearance as substantially equivalent to a predicate device.

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

13 devices
1–13 of 13
HEARLAB ACA
K123701 · GWJ Stimulator, Auditory,... · Neurology
Apr 2013 123d
FONIX ,MODEL 8000
K093006 · ETW Calibrator, Hearing Aid /... · Ear, Nose, Throat
Dec 2009 93d
FONIX, MODEL 7000
K022510 · ETW Calibrator, Hearing Aid /... · Ear, Nose, Throat
Aug 2002 28d
FONIX FP35 HEARING AID ANALYZER
K980377 · ETW Calibrator, Hearing Aid /... · Ear, Nose, Throat
Mar 1998 44d
FONIX 3500 HEARING AID ANALYZER
K935400 · ETW Calibrator, Hearing Aid /... · Ear, Nose, Throat
Jan 1994 66d
TYPE FA10 AUDIOMETER
K913221 · EWO Audiometer · Ear, Nose, Throat
Oct 1991 84d
TYPE FP40 DIGITAL HEARING AID ANALYZER
K895383 · ETW Calibrator, Hearing Aid /... · Ear, Nose, Throat
Jan 1990 145d
TYPE 6400 REAL EAR HEARING AID ANALYZER
K872242 · ETW Calibrator, Hearing Aid /... · Ear, Nose, Throat
Jul 1987 29d
TYPE 6500 HEARING AID ANALYZER
K861571 · ETW Calibrator, Hearing Aid /... · Ear, Nose, Throat
May 1986 32d
TYPE FP30 DIGITAL HEARING AID ANALYZER
K850918 · ETW Calibrator, Hearing Aid /... · Ear, Nose, Throat
May 1985 85d
DIGITAL AUDIOMETER/HEARING AID 3100
K833883 · EWO Audiometer · Ear, Nose, Throat
Feb 1984 104d
FONIX TYPE 5100 HEARING AID ANALYZER
K801905 · ETW Calibrator, Hearing Aid /... · Ear, Nose, Throat
Aug 1980 16d
TYPE 4000 TRANSCUTANEOUS ELEC. STIM.
K800630 · GZJ Stimulator, Nerve,... · Neurology
Apr 1980 13d
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