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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
Jul 12, 1995K943616BELTONE PERSONAL HEARING SCREENER
Beltone Electronics Corp.
EWO
Jul 6, 1995K951759GSI 65 COMPUTERIZED AUDIOMETER
Grason-Stadler, Inc.
EWO
May 12, 1995K943215DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER
Kenneth Ullrich
EWO
May 3, 1995K951527THE PILOT AUDIOMETER
American Electromedics Corp.
EWO
Apr 11, 1995K945199RH2000 REAL EAR MEASUREMENT SYSTEM
Madsen Electronics, Inc.
EWO
Mar 21, 1995K950888SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY
Calmed Technology, Inc.
EWO
Feb 8, 1995K945689GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM)
Calmed Technology, Inc.
EWO
Feb 2, 1995K945032VOYAGER 522
Madsen Electronics, Inc.
EWO
Dec 21, 1994K944735BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST
Bio-Logic Systems Corp.
EWO
Sep 16, 1994K941920INTERACOUSTICS CLINICAL AUDIOMETER
Precision Acoustics Ind., Inc.
EWO
Sep 2, 1994K942716AUDIO EXPERT AUDIOMETER
Beltone Electronics Corp.
EWO
Aug 24, 1994K943066INTERACOUSTICS COMPUTER AUDIOMETER BA 20
Precision Acoustics Ind., Inc.
EWO
Aug 19, 1994K931322KS 5 - CLINICAL AUDIOMETER
Maico Hearing Instruments, Inc.
EWO
Aug 17, 1994K943065INTERACOUSTICS CLINICAL AUDIOMETER
Precision Acoustics Ind., Inc.
EWO
Jul 29, 1994K940216BELTONE SERIES 100 AUDIOMETERS
Beltone Electronics Corp.
EWO
Jul 7, 1994K935719DAIL A HEARING SCREENING TEST
Occupational Hearing Services
EWO
Jun 20, 1994K942006INTERACOUSTICS DIAGNOSTIC AUDIOMETER
Precision Acoustics Ind., Inc.
EWO
May 10, 1994K934715MODEL 222 CLINICAL AUDIOMETER
Virtual Corp.
EWO
Apr 22, 1994K940999PRODIGIT 2000
Calmed Technology, Inc.
EWO
Feb 18, 1994K931325OTOACOUSTIC EMISSIONS UNIT CELESTA 503
Madsen Electronics (Canada) , Ltd.
EWO
Feb 9, 1994K935348ODYSSEY CLINICAL AUDIOMETER
Qualitone
EWO
Feb 1, 1994K934658GSI 60 DPOAE SYSTEM
Lucas Grason-Stadler, Inc.
EWO
Jan 24, 1994K933097SOUND SELECTOR FULL-SERVICE AUDIOMETER
Ensoniq Corp.
EWO
Jan 21, 1994K934343GLASER RT60, RT80, RT150 AUDIOMETER
Glaser Instruments AG, CH
EWO
Nov 24, 1993K933220SELECTOR SL 01
Futuremed Div. of Future Impex Corp.
EWO
Nov 19, 1993K931324ORBITER 922 CLINICAL AUDIOMETER
Madsen Electronics (Canada) , Ltd.
EWO
Nov 1, 1993K933222AUDIOMETER DA 323
Futuremed Div. of Future Impex Corp.
EWO
Sep 29, 1993K930553CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT
Etymotic Research
EWO
Aug 5, 1993K930112MAICO MA790 AUDIOMETER
Maico Hearing Instruments, Inc.
EWO
Aug 5, 1993K926439MA25 - PORTABLE AUDIOMETER, MODIFICATION
Maico Hearing Instruments, Inc.
EWO
Jul 13, 1993K930260ACOUSTIC ANALYZER AA30
Precision Acoustics Ind., Inc.
EWO
Jun 18, 1993K930003TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES
Etymotic Research
EWO
Mar 4, 1993K926336AUDIOSCAN
Electrocaine Medical System
EWO
Feb 26, 1993K924543DSP SCREENING AUDIOMETER
Micro Audiometrics Corp.
EWO
Feb 26, 1993K923007AT-2
Qualitone
EWO
Jan 15, 1993K922383THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO
Monitor Instruments, Inc.
EWO
Nov 5, 1992K922746ST 20 PORTABLE AUDIOMETER
Maico Hearing Instruments, Inc.
EWO
Sep 23, 1992K923074DANPLEX SCREENING AUDIOMETER
Life-Tech Intl., Inc.
EWO
Aug 14, 1992K923013ACOUSTIC APPRAISE CD-3
Qualitone
EWO
May 15, 1992K921085PROGRAMMED AUDIOMETRIC DEVICE (PAD)/RECORS (PAR)
Hear-Well Technologies, Inc., CA
EWO
May 11, 1992K915323THE BELTONE AUDIO SCOUT
Beltone Electronics Corp.
EWO
Jan 31, 1992K914232ASRA, SCREENING AUDIOMETER
Mercury Electronics (Scot) , Ltd., GB
EWO
Dec 5, 1991K913356THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER
Monitor Instruments, Inc.
EWO
Nov 5, 1991K913589EARSCAN DSP-1 PURE TONE AUDIOMETER
Micro Audiometrics Corp.
EWO
Oct 21, 1991K913276MICROTEK MEDICAL'S SOUND STIKS
Microbio-Medics, Inc.
EWO
Oct 21, 1991K911689MODEL 330 SCREENING AUDIOMETER
Virtual Corp.
EWO
Oct 11, 1991K913221TYPE FA10 AUDIOMETER
Frye Electronics, Inc.
EWO
Sep 17, 1991K904622HEARING CHECKER(TM), DESKTOP MODEL
Qualitone Hearing Aids and Audiometers
EWO
Sep 16, 1991K912669RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
Resound Corp.
EWO
Jun 26, 1991K911368MAICO MA800 AUDIOMETER
Maico Hearing Instruments, Inc.
EWO

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