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EWO

235 FDA 510(k) clearances · Product code

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RecordFirmDate
BELTONE PERSONAL HEARING SCREENER (K943616)Beltone Electronics Corp.1995-07-12
GSI 65 COMPUTERIZED AUDIOMETER (K951759)Grason-Stadler, Inc.1995-07-06
DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER (K943215)Kenneth Ullrich1995-05-12
THE PILOT AUDIOMETER (K951527)American Electromedics Corp.1995-05-03
RH2000 REAL EAR MEASUREMENT SYSTEM (K945199)Madsen Electronics, Inc.1995-04-11
SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY (K950888)Calmed Technology, Inc.1995-03-21
GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM) (K945689)Calmed Technology, Inc.1995-02-08
VOYAGER 522 (K945032)Madsen Electronics, Inc.1995-02-02
BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST (K944735)Bio-Logic Systems Corp.1994-12-21
INTERACOUSTICS CLINICAL AUDIOMETER (K941920)Precision Acoustics Ind., Inc.1994-09-16
AUDIO EXPERT AUDIOMETER (K942716)Beltone Electronics Corp.1994-09-02
INTERACOUSTICS COMPUTER AUDIOMETER BA 20 (K943066)Precision Acoustics Ind., Inc.1994-08-24
KS 5 - CLINICAL AUDIOMETER (K931322)Maico Hearing Instruments, Inc.1994-08-19
INTERACOUSTICS CLINICAL AUDIOMETER (K943065)Precision Acoustics Ind., Inc.1994-08-17
BELTONE SERIES 100 AUDIOMETERS (K940216)Beltone Electronics Corp.1994-07-29
DAIL A HEARING SCREENING TEST (K935719)Occupational Hearing Services1994-07-07
INTERACOUSTICS DIAGNOSTIC AUDIOMETER (K942006)Precision Acoustics Ind., Inc.1994-06-20
MODEL 222 CLINICAL AUDIOMETER (K934715)Virtual Corp.1994-05-10
PRODIGIT 2000 (K940999)Calmed Technology, Inc.1994-04-22
OTOACOUSTIC EMISSIONS UNIT CELESTA 503 (K931325)Madsen Electronics (Canada) , Ltd.1994-02-18
ODYSSEY CLINICAL AUDIOMETER (K935348)Qualitone1994-02-09
GSI 60 DPOAE SYSTEM (K934658)Lucas Grason-Stadler, Inc.1994-02-01
SOUND SELECTOR FULL-SERVICE AUDIOMETER (K933097)Ensoniq Corp.1994-01-24
GLASER RT60, RT80, RT150 AUDIOMETER (K934343)Glaser Instruments AG1994-01-21
SELECTOR SL 01 (K933220)Futuremed Div. of Future Impex Corp.1993-11-24
ORBITER 922 CLINICAL AUDIOMETER (K931324)Madsen Electronics (Canada) , Ltd.1993-11-19
AUDIOMETER DA 323 (K933222)Futuremed Div. of Future Impex Corp.1993-11-01
CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT (K930553)Etymotic Research1993-09-29
MA25 - PORTABLE AUDIOMETER, MODIFICATION (K926439)Maico Hearing Instruments, Inc.1993-08-05
MAICO MA790 AUDIOMETER (K930112)Maico Hearing Instruments, Inc.1993-08-05
ACOUSTIC ANALYZER AA30 (K930260)Precision Acoustics Ind., Inc.1993-07-13
TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES (K930003)Etymotic Research1993-06-18
AUDIOSCAN (K926336)Electrocaine Medical System1993-03-04
DSP SCREENING AUDIOMETER (K924543)Micro Audiometrics Corp.1993-02-26
AT-2 (K923007)Qualitone1993-02-26
THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO (K922383)Monitor Instruments, Inc.1993-01-15
ST 20 PORTABLE AUDIOMETER (K922746)Maico Hearing Instruments, Inc.1992-11-05
DANPLEX SCREENING AUDIOMETER (K923074)Life-Tech Intl., Inc.1992-09-23
ACOUSTIC APPRAISE CD-3 (K923013)Qualitone1992-08-14
PROGRAMMED AUDIOMETRIC DEVICE (PAD)/RECORS (PAR) (K921085)Hear-Well Technologies, Inc.1992-05-15
THE BELTONE AUDIO SCOUT (K915323)Beltone Electronics Corp.1992-05-11
ASRA, SCREENING AUDIOMETER (K914232)Mercury Electronics (Scot) , Ltd.1992-01-31
THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER (K913356)Monitor Instruments, Inc.1991-12-05
EARSCAN DSP-1 PURE TONE AUDIOMETER (K913589)Micro Audiometrics Corp.1991-11-05
MODEL 330 SCREENING AUDIOMETER (K911689)Virtual Corp.1991-10-21
MICROTEK MEDICAL'S SOUND STIKS (K913276)Microbio-Medics, Inc.1991-10-21
TYPE FA10 AUDIOMETER (K913221)Frye Electronics, Inc.1991-10-11
HEARING CHECKER(TM), DESKTOP MODEL (K904622)Qualitone Hearing Aids and Audiometers1991-09-17
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM (K912669)Resound Corp.1991-09-16
MAICO MA800 AUDIOMETER (K911368)Maico Hearing Instruments, Inc.1991-06-26
THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER (K900197)Sound Linked Data, Inc.1991-04-17
ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID (K904544)Qualitone1990-10-31
BIOLINK AUDIOMETER SOFTWARE ACCESSORY (K904270)Micro Audiometrics Corp.1990-10-09
OTOSCREENER-I AND OTO-SCREEN-I-P (K903143)Handtronix, Inc.1990-09-19
HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER (K902068)Starkey Laboratories, Inc.1990-08-06
GSI 17 SCREENING AUDIOMETER (K902540)Grason-Stadler, Inc.1990-07-13
AUDIOTESTER SCREENING AUDIOMETER (K894484)Prometex, Inc.1990-06-26
INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA) (K900096)Artifical Hearing Systems Corp.1990-05-31
MIDIMATE 622 (K896710)Madsen North America, Inc.1990-04-13
MICROMATE 304 (K896401)Madsen North America, Inc.1990-03-27
MD5 AUTOMATIC AUDIOMETER (K896909)Singer Medical Products, Inc.1990-03-05
AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7 (K895310)Maico Hearing Instruments, Inc.1990-01-23
MODEL EB-22 NOISE STIK (K895200)Eckstein Brothers, Inc.1990-01-22
AUDIOMETER MODEL MD-4, MD-4P (K895785)Singer Medical Products, Inc.1989-12-05
IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P (K894748)Singer Medical Products, Inc.1989-12-05
IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3 (K895784)Singer Medical Products, Inc.1989-12-05
AMPLAID A308 CLINICAL AUDIOMETER (K891988)Amplus Corp.1989-10-12
AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID (K890993)Maico Hearing Instruments, Inc.1989-10-12
BIOMETER AUDIOMETER (K883505)Micro Audiometrics Corp.1989-08-21
TRACOR RA500 AUDIOMETER (K891373)Tracor Instruments Austin, Inc.1989-07-14
ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER (K890124)Grason-Stadler, Inc.1989-07-14
2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY (K890842)Maico Hearing Instruments, Inc.1989-06-07
MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER (K890497)Monitor/Demlar1989-06-06
AUDIOSCOPE 3 MODEL 23300 ACCESSORIES (K884218)Welch Allyn, Inc.1989-03-10
AUDIOMETER DIGITAL HEARING SYSTEM (K884044)Resound Corp.1989-02-22
OTOMETER PORTABLE SCREENING AUDIOMETER (K883169)Otometer, Inc.1988-12-07
DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602 (K883478)Madsen Electronics (Canada) , Ltd.1988-11-17
AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER (K881760)American Electromedics Corp.1988-06-10
AMPLAID 309 CLINICAL AUDIOMETER (K880059)Amplus Corp.1988-02-23
THE BELTONE 2000 AUDIOMETER (K875360)Beltone Electronics Corp.1988-02-17
MODEL V4 AUDIOMETER (K874516)Digital Hearing Systems Corp.1987-12-14
PLAYTONE AUDIOMETER (K872042)Sensory Aids Corp.1987-08-11
MODEL 320 TWO CHANNEL AUDIOMETER (K863984)Virtual Corp.1986-11-18
MICROSCREEN I HEARING TESTER (K863979)Microscreen1986-11-18
PHOENIX SYSTEM SEVEN. (K862592)Nicolet Biomedical Instruments1986-09-16
AUDIOMETER/MASTER HEARING AID MF6 (K862770)Maico Hearing Instruments, Inc.1986-08-15
DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER (K854835)Miracle-Ear/Dahlberg, Inc.1986-03-04
DIGITAL SCREENING AUDIOMETER DSA6214 (K854534)Madsen Electronics (Canada) , Ltd.1986-02-13
CRAIGWELL AID FITTING SYSTEM AFS (K854125)Craigwell Electronics, Ltd.1986-01-16
MA25 PORTABLE AUDIOMETER (K853919)Maico Hearing Instruments, Inc.1985-12-18
TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER (K853245)Tracor Instruments, Inc.1985-10-16
TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200 (K851392)Tracor Instruments, Inc.1985-06-20
TA-20 AUTOMATIC INDUSTIRAL AUDIOMETER (K851015)Teledyne Avionics Div. of Teledyne1985-06-04
UP800 A UNIVERSAL PRINTER (K845050)Madsen Electronics (Canada) , Ltd.1985-05-29
TA-201 CLINICAL AUDIOMETER (K844069)Teledyne Avionics Div. of Teledyne1984-12-03
AUDIOMETER (K843618)Grason-Stadler, Inc.1984-12-03
AUDIOMETER MA728 (K841567)Maico Hearing Instruments, Inc.1984-06-27
DEMLAR SYS I COMPUTER BASED AUDIOMETER (K841167)Demlar Medical, Inc.1984-06-27
DIGITAL AUDIOMETER/HEARING AID 3100 (K833883)Frye Electronics, Inc.1984-02-21
AUDIOMETER MODEL-500 (K831431)Audimax1983-06-30
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