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Panels › Ear, Nose, Throat › Product code EWO · Class 2

Audiometer

Regulation 874.1050

0510(k)s in 12 months (235 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
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Top companies in EWO

Company510(k)sRecalls
Maico Hearing Instruments, Inc.200
Grason-Stadler, Inc.120
Bio-Logic Systems Corp.90
Etymotic Research80
Otodynamics80
Tracor Instruments, Inc.70
American Electromedics Corp.60
Micro Audiometrics Corp.60
Beltone Electronics Corp.50
Madsen Electronics (Canada) , Ltd.50
Decided510(k)Device and applicantCode
Apr 17, 1991K900197THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER
Sound Linked Data, Inc., CA
EWO
Oct 31, 1990K904544ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID
Qualitone
EWO
Oct 9, 1990K904270BIOLINK AUDIOMETER SOFTWARE ACCESSORY
Micro Audiometrics Corp.
EWO
Sep 19, 1990K903143OTOSCREENER-I AND OTO-SCREEN-I-P
Handtronix, Inc.
EWO
Aug 6, 1990K902068HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER
Starkey Laboratories, Inc.
EWO
Jul 13, 1990K902540GSI 17 SCREENING AUDIOMETER
Grason-Stadler, Inc.
EWO
Jun 26, 1990K894484AUDIOTESTER SCREENING AUDIOMETER
Prometex, Inc.
EWO
May 31, 1990K900096INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)
Artifical Hearing Systems Corp.
EWO
Apr 13, 1990K896710MIDIMATE 622
Madsen North America, Inc.
EWO
Mar 27, 1990K896401MICROMATE 304
Madsen North America, Inc.
EWO
Mar 5, 1990K896909MD5 AUTOMATIC AUDIOMETER
Singer Medical Products, Inc.
EWO
Jan 23, 1990K895310AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7
Maico Hearing Instruments, Inc.
EWO
Jan 22, 1990K895200MODEL EB-22 NOISE STIK
Eckstein Brothers, Inc.
EWO
Dec 5, 1989K895785AUDIOMETER MODEL MD-4, MD-4P
Singer Medical Products, Inc.
EWO
Dec 5, 1989K895784IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3
Singer Medical Products, Inc.
EWO
Dec 5, 1989K894748IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P
Singer Medical Products, Inc.
EWO
Oct 12, 1989K891988AMPLAID A308 CLINICAL AUDIOMETER
Amplus Corp.
EWO
Oct 12, 1989K890993AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID
Maico Hearing Instruments, Inc.
EWO
Aug 21, 1989K883505BIOMETER AUDIOMETER
Micro Audiometrics Corp.
EWO
Jul 14, 1989K891373TRACOR RA500 AUDIOMETER
Tracor Instruments Austin, Inc.
EWO
Jul 14, 1989K890124ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER
Grason-Stadler, Inc.
EWO
Jun 7, 1989K8908422400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY
Maico Hearing Instruments, Inc.
EWO
Jun 6, 1989K890497MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER
Monitor/Demlar
EWO
Mar 10, 1989K884218AUDIOSCOPE 3 MODEL 23300 ACCESSORIES
Welch Allyn, Inc.
EWO
Feb 22, 1989K884044AUDIOMETER DIGITAL HEARING SYSTEM
Resound Corp.
EWO
Dec 7, 1988K883169OTOMETER PORTABLE SCREENING AUDIOMETER
Otometer, Inc.
EWO
Nov 17, 1988K883478DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602
Madsen Electronics (Canada) , Ltd., CA
EWO
Jun 10, 1988K881760AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER
American Electromedics Corp.
EWO
Feb 23, 1988K880059AMPLAID 309 CLINICAL AUDIOMETER
Amplus Corp.
EWO
Feb 17, 1988K875360THE BELTONE 2000 AUDIOMETER
Beltone Electronics Corp.
EWO
Dec 14, 1987K874516MODEL V4 AUDIOMETER
Digital Hearing Systems Corp.
EWO
Aug 11, 1987K872042PLAYTONE AUDIOMETER
Sensory Aids Corp.
EWO
Nov 18, 1986K863984MODEL 320 TWO CHANNEL AUDIOMETER
Virtual Corp.
EWO
Nov 18, 1986K863979MICROSCREEN I HEARING TESTER
Microscreen
EWO
Sep 16, 1986K862592PHOENIX SYSTEM SEVEN.
Nicolet Biomedical Instruments
EWO
Aug 15, 1986K862770AUDIOMETER/MASTER HEARING AID MF6
Maico Hearing Instruments, Inc.
EWO
Mar 4, 1986K854835DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER
Miracle-Ear/Dahlberg, Inc.
EWO
Feb 13, 1986K854534DIGITAL SCREENING AUDIOMETER DSA6214
Madsen Electronics (Canada) , Ltd., CA
EWO
Jan 16, 1986K854125CRAIGWELL AID FITTING SYSTEM AFS
Craigwell Electronics, Ltd., GB
EWO
Dec 18, 1985K853919MA25 PORTABLE AUDIOMETER
Maico Hearing Instruments, Inc.
EWO
Oct 16, 1985K853245TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER
Tracor Instruments, Inc.
EWO
Jun 20, 1985K851392TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200
Tracor Instruments, Inc.
EWO
Jun 4, 1985K851015TA-20 AUTOMATIC INDUSTIRAL AUDIOMETER
Teledyne Avionics Div. of Teledyne
EWO
May 29, 1985K845050UP800 A UNIVERSAL PRINTER
Madsen Electronics (Canada) , Ltd., CA
EWO
Dec 3, 1984K844069TA-201 CLINICAL AUDIOMETER
Teledyne Avionics Div. of Teledyne
EWO
Dec 3, 1984K843618AUDIOMETER
Grason-Stadler, Inc.
EWO
Jun 27, 1984K841567AUDIOMETER MA728
Maico Hearing Instruments, Inc.
EWO
Jun 27, 1984K841167DEMLAR SYS I COMPUTER BASED AUDIOMETER
Demlar Medical, Inc.
EWO
Feb 21, 1984K833883DIGITAL AUDIOMETER/HEARING AID 3100
Frye Electronics, Inc.
EWO
Jun 30, 1983K831431AUDIOMETER MODEL-500
Audimax
EWO

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