EWO · Class II · 21 CFR 874.1050

FDA Product Code EWO: Audiometer

Leading manufacturers include Maico Hearing Instruments, Inc., Bio-Logic Systems Corp. and Otodynamics, Ltd..

235
Total
235
Cleared
103d
Avg days
1976
Since
235 devices
97–120 of 235
Cleared Sep 23, 1992
DANPLEX SCREENING AUDIOMETER
K923074
Life-Tech Intl., Inc.
Ear, Nose, Throat · 90d
Cleared Aug 14, 1992
ACOUSTIC APPRAISE CD-3
K923013
Qualitone
Ear, Nose, Throat · 53d
Cleared May 11, 1992
THE BELTONE AUDIO SCOUT
K915323
Beltone Electronics Corp.
Ear, Nose, Throat · 171d
Cleared Sep 16, 1991
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
K912669
Resound Corp.
Ear, Nose, Throat · 90d
Cleared Jun 26, 1991
MAICO MA800 AUDIOMETER
K911368
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 90d
Cleared Oct 31, 1990
ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID
K904544
Qualitone
Ear, Nose, Throat · 27d
Cleared Aug 06, 1990
HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER
K902068
Starkey Laboratories, Inc.
Ear, Nose, Throat · 91d
Cleared Jan 23, 1990
AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7
K895310
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 147d
Cleared Oct 12, 1989
AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID
K890993
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 227d
Cleared Jun 07, 1989
2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY
K890842
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 106d
Cleared Mar 10, 1989
AUDIOSCOPE 3 MODEL 23300 ACCESSORIES
K884218
Welch Allyn, Inc.
Ear, Nose, Throat · 155d
Cleared Feb 22, 1989
AUDIOMETER DIGITAL HEARING SYSTEM
K884044
Resound Corp.
Ear, Nose, Throat · 149d
Cleared Nov 17, 1988
DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602
K883478
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 93d
Cleared Jun 10, 1988
AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER
K881760
American Electromedics Corp.
Ear, Nose, Throat · 46d
Cleared Feb 17, 1988
THE BELTONE 2000 AUDIOMETER
K875360
Beltone Electronics Corp.
Ear, Nose, Throat · 48d
Cleared Sep 16, 1986
PHOENIX SYSTEM SEVEN.
K862592
Nicolet Biomedical Instruments
Ear, Nose, Throat · 70d
Cleared Aug 15, 1986
AUDIOMETER/MASTER HEARING AID MF6
K862770
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 24d
Cleared Mar 04, 1986
DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER
K854835
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 91d
Cleared Feb 13, 1986
DIGITAL SCREENING AUDIOMETER DSA6214
K854534
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 92d
Cleared Dec 18, 1985
MA25 PORTABLE AUDIOMETER
K853919
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 86d
Cleared May 29, 1985
UP800 A UNIVERSAL PRINTER
K845050
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 184d
Cleared Jun 27, 1984
AUDIOMETER MA728
K841567
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 71d
Cleared Sep 30, 1982
THE SCREENING TYMPANOMETER
K822745
American Electromedics Corp.
Ear, Nose, Throat · 20d
Cleared Jul 15, 1981
PORTABLE AUDIOMETERS
K811727
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 27d