FDA Product Code
FDA Product Code EWO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.1050
510(k) Clearances — 235 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K943616 | BELTONE PERSONAL HEARING SCREENER | Beltone Electronics Corp. | 1995-07-12 | Traditional | PDF ↗ |
| K951759 | GSI 65 COMPUTERIZED AUDIOMETER | Grason-Stadler, Inc. | 1995-07-06 | Traditional | PDF ↗ |
| K943215 | DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER | Kenneth Ullrich | 1995-05-12 | Traditional | PDF ↗ |
| K951527 | THE PILOT AUDIOMETER | American Electromedics Corp. | 1995-05-03 | Traditional | PDF ↗ |
| K945199 | RH2000 REAL EAR MEASUREMENT SYSTEM | Madsen Electronics, Inc. | 1995-04-11 | Traditional | PDF ↗ |
| K950888 | SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY | Calmed Technology, Inc. | 1995-03-21 | Traditional | PDF ↗ |
| K945689 | GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM) | Calmed Technology, Inc. | 1995-02-08 | Traditional | PDF ↗ |
| K945032 | VOYAGER 522 | Madsen Electronics, Inc. | 1995-02-02 | Traditional | PDF ↗ |
| K944735 | BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST | Bio-Logic Systems Corp. | 1994-12-21 | Traditional | PDF ↗ |
| K941920 | INTERACOUSTICS CLINICAL AUDIOMETER | Precision Acoustics Ind., Inc. | 1994-09-16 | Traditional | PDF ↗ |
| K942716 | AUDIO EXPERT AUDIOMETER | Beltone Electronics Corp. | 1994-09-02 | Traditional | PDF ↗ |
| K943066 | INTERACOUSTICS COMPUTER AUDIOMETER BA 20 | Precision Acoustics Ind., Inc. | 1994-08-24 | Traditional | PDF ↗ |
| K931322 | KS 5 - CLINICAL AUDIOMETER | Maico Hearing Instruments, Inc. | 1994-08-19 | Traditional | PDF ↗ |
| K943065 | INTERACOUSTICS CLINICAL AUDIOMETER | Precision Acoustics Ind., Inc. | 1994-08-17 | Traditional | PDF ↗ |
| K940216 | BELTONE SERIES 100 AUDIOMETERS | Beltone Electronics Corp. | 1994-07-29 | Traditional | PDF ↗ |
| K935719 | DAIL A HEARING SCREENING TEST | Occupational Hearing Services | 1994-07-07 | Traditional | PDF ↗ |
| K942006 | INTERACOUSTICS DIAGNOSTIC AUDIOMETER | Precision Acoustics Ind., Inc. | 1994-06-20 | Traditional | PDF ↗ |
| K934715 | MODEL 222 CLINICAL AUDIOMETER | Virtual Corp. | 1994-05-10 | Traditional | PDF ↗ |
| K940999 | PRODIGIT 2000 | Calmed Technology, Inc. | 1994-04-22 | Traditional | PDF ↗ |
| K931325 | OTOACOUSTIC EMISSIONS UNIT CELESTA 503 | Madsen Electronics (Canada) , Ltd. | 1994-02-18 | Traditional | PDF ↗ |
| K935348 | ODYSSEY CLINICAL AUDIOMETER | Qualitone | 1994-02-09 | Traditional | PDF ↗ |
| K934658 | GSI 60 DPOAE SYSTEM | Lucas Grason-Stadler, Inc. | 1994-02-01 | Traditional | PDF ↗ |
| K933097 | SOUND SELECTOR FULL-SERVICE AUDIOMETER | Ensoniq Corp. | 1994-01-24 | Traditional | PDF ↗ |
| K934343 | GLASER RT60, RT80, RT150 AUDIOMETER | Glaser Instruments AG | 1994-01-21 | Traditional | PDF ↗ |
| K933220 | SELECTOR SL 01 | Futuremed Div. of Future Impex Corp. | 1993-11-24 | Traditional | PDF ↗ |
| K931324 | ORBITER 922 CLINICAL AUDIOMETER | Madsen Electronics (Canada) , Ltd. | 1993-11-19 | Traditional | PDF ↗ |
| K933222 | AUDIOMETER DA 323 | Futuremed Div. of Future Impex Corp. | 1993-11-01 | Traditional | PDF ↗ |
| K930553 | CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT | Etymotic Research | 1993-09-29 | Traditional | PDF ↗ |
| K926439 | MA25 - PORTABLE AUDIOMETER, MODIFICATION | Maico Hearing Instruments, Inc. | 1993-08-05 | Traditional | PDF ↗ |
| K930112 | MAICO MA790 AUDIOMETER | Maico Hearing Instruments, Inc. | 1993-08-05 | Traditional | PDF ↗ |
| K930260 | ACOUSTIC ANALYZER AA30 | Precision Acoustics Ind., Inc. | 1993-07-13 | Traditional | PDF ↗ |
| K930003 | TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES | Etymotic Research | 1993-06-18 | Traditional | PDF ↗ |
| K926336 | AUDIOSCAN | Electrocaine Medical System | 1993-03-04 | Traditional | PDF ↗ |
| K924543 | DSP SCREENING AUDIOMETER | Micro Audiometrics Corp. | 1993-02-26 | Traditional | PDF ↗ |
| K923007 | AT-2 | Qualitone | 1993-02-26 | Traditional | PDF ↗ |
| K922383 | THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO | Monitor Instruments, Inc. | 1993-01-15 | Traditional | PDF ↗ |
| K922746 | ST 20 PORTABLE AUDIOMETER | Maico Hearing Instruments, Inc. | 1992-11-05 | Traditional | PDF ↗ |
| K923074 | DANPLEX SCREENING AUDIOMETER | Life-Tech Intl., Inc. | 1992-09-23 | Traditional | PDF ↗ |
| K923013 | ACOUSTIC APPRAISE CD-3 | Qualitone | 1992-08-14 | Traditional | PDF ↗ |
| K921085 | PROGRAMMED AUDIOMETRIC DEVICE (PAD)/RECORS (PAR) | Hear-Well Technologies, Inc. | 1992-05-15 | Traditional | PDF ↗ |
| K915323 | THE BELTONE AUDIO SCOUT | Beltone Electronics Corp. | 1992-05-11 | Traditional | PDF ↗ |
| K914232 | ASRA, SCREENING AUDIOMETER | Mercury Electronics (Scot) , Ltd. | 1992-01-31 | Traditional | PDF ↗ |
| K913356 | THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER | Monitor Instruments, Inc. | 1991-12-05 | Traditional | PDF ↗ |
| K913589 | EARSCAN DSP-1 PURE TONE AUDIOMETER | Micro Audiometrics Corp. | 1991-11-05 | Traditional | PDF ↗ |
| K911689 | MODEL 330 SCREENING AUDIOMETER | Virtual Corp. | 1991-10-21 | Traditional | PDF ↗ |
| K913276 | MICROTEK MEDICAL'S SOUND STIKS | Microbio-Medics, Inc. | 1991-10-21 | Traditional | PDF ↗ |
| K913221 | TYPE FA10 AUDIOMETER | Frye Electronics, Inc. | 1991-10-11 | Traditional | PDF ↗ |
| K904622 | HEARING CHECKER(TM), DESKTOP MODEL | Qualitone Hearing Aids and Audiometers | 1991-09-17 | Traditional | PDF ↗ |
| K912669 | RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM | Resound Corp. | 1991-09-16 | Traditional | PDF ↗ |
| K911368 | MAICO MA800 AUDIOMETER | Maico Hearing Instruments, Inc. | 1991-06-26 | Traditional | PDF ↗ |
| K900197 | THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER | Sound Linked Data, Inc. | 1991-04-17 | Traditional | PDF ↗ |
| K904544 | ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID | Qualitone | 1990-10-31 | Traditional | PDF ↗ |
| K904270 | BIOLINK AUDIOMETER SOFTWARE ACCESSORY | Micro Audiometrics Corp. | 1990-10-09 | Traditional | PDF ↗ |
| K903143 | OTOSCREENER-I AND OTO-SCREEN-I-P | Handtronix, Inc. | 1990-09-19 | Traditional | PDF ↗ |
| K902068 | HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER | Starkey Laboratories, Inc. | 1990-08-06 | Traditional | PDF ↗ |
| K902540 | GSI 17 SCREENING AUDIOMETER | Grason-Stadler, Inc. | 1990-07-13 | Traditional | PDF ↗ |
| K894484 | AUDIOTESTER SCREENING AUDIOMETER | Prometex, Inc. | 1990-06-26 | Traditional | PDF ↗ |
| K900096 | INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA) | Artifical Hearing Systems Corp. | 1990-05-31 | Traditional | PDF ↗ |
| K896710 | MIDIMATE 622 | Madsen North America, Inc. | 1990-04-13 | Traditional | PDF ↗ |
| K896401 | MICROMATE 304 | Madsen North America, Inc. | 1990-03-27 | Traditional | PDF ↗ |
| K896909 | MD5 AUTOMATIC AUDIOMETER | Singer Medical Products, Inc. | 1990-03-05 | Traditional | PDF ↗ |
| K895310 | AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7 | Maico Hearing Instruments, Inc. | 1990-01-23 | Traditional | PDF ↗ |
| K895200 | MODEL EB-22 NOISE STIK | Eckstein Brothers, Inc. | 1990-01-22 | Traditional | PDF ↗ |
| K894748 | IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P | Singer Medical Products, Inc. | 1989-12-05 | Traditional | PDF ↗ |
| K895785 | AUDIOMETER MODEL MD-4, MD-4P | Singer Medical Products, Inc. | 1989-12-05 | Traditional | PDF ↗ |
| K895784 | IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3 | Singer Medical Products, Inc. | 1989-12-05 | Traditional | PDF ↗ |
| K891988 | AMPLAID A308 CLINICAL AUDIOMETER | Amplus Corp. | 1989-10-12 | Traditional | PDF ↗ |
| K890993 | AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID | Maico Hearing Instruments, Inc. | 1989-10-12 | Traditional | PDF ↗ |
| K883505 | BIOMETER AUDIOMETER | Micro Audiometrics Corp. | 1989-08-21 | Traditional | PDF ↗ |
| K891373 | TRACOR RA500 AUDIOMETER | Tracor Instruments Austin, Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K890124 | ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER | Grason-Stadler, Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K890842 | 2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY | Maico Hearing Instruments, Inc. | 1989-06-07 | Traditional | PDF ↗ |
| K890497 | MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER | Monitor/Demlar | 1989-06-06 | Traditional | PDF ↗ |
| K884218 | AUDIOSCOPE 3 MODEL 23300 ACCESSORIES | Welch Allyn, Inc. | 1989-03-10 | Traditional | PDF ↗ |
| K884044 | AUDIOMETER DIGITAL HEARING SYSTEM | Resound Corp. | 1989-02-22 | Traditional | PDF ↗ |
| K883169 | OTOMETER PORTABLE SCREENING AUDIOMETER | Otometer, Inc. | 1988-12-07 | Traditional | PDF ↗ |
| K883478 | DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602 | Madsen Electronics (Canada) , Ltd. | 1988-11-17 | Traditional | PDF ↗ |
| K881760 | AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER | American Electromedics Corp. | 1988-06-10 | Traditional | PDF ↗ |
| K880059 | AMPLAID 309 CLINICAL AUDIOMETER | Amplus Corp. | 1988-02-23 | Traditional | PDF ↗ |
| K875360 | THE BELTONE 2000 AUDIOMETER | Beltone Electronics Corp. | 1988-02-17 | Traditional | PDF ↗ |
| K874516 | MODEL V4 AUDIOMETER | Digital Hearing Systems Corp. | 1987-12-14 | Traditional | PDF ↗ |
| K872042 | PLAYTONE AUDIOMETER | Sensory Aids Corp. | 1987-08-11 | Traditional | PDF ↗ |
| K863979 | MICROSCREEN I HEARING TESTER | Microscreen | 1986-11-18 | Traditional | PDF ↗ |
| K863984 | MODEL 320 TWO CHANNEL AUDIOMETER | Virtual Corp. | 1986-11-18 | Traditional | PDF ↗ |
| K862592 | PHOENIX SYSTEM SEVEN. | Nicolet Biomedical Instruments | 1986-09-16 | Traditional | PDF ↗ |
| K862770 | AUDIOMETER/MASTER HEARING AID MF6 | Maico Hearing Instruments, Inc. | 1986-08-15 | Traditional | PDF ↗ |
| K854835 | DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER | Miracle-Ear/Dahlberg, Inc. | 1986-03-04 | Traditional | PDF ↗ |
| K854534 | DIGITAL SCREENING AUDIOMETER DSA6214 | Madsen Electronics (Canada) , Ltd. | 1986-02-13 | Traditional | PDF ↗ |
| K854125 | CRAIGWELL AID FITTING SYSTEM AFS | Craigwell Electronics, Ltd. | 1986-01-16 | Traditional | PDF ↗ |
| K853919 | MA25 PORTABLE AUDIOMETER | Maico Hearing Instruments, Inc. | 1985-12-18 | Traditional | PDF ↗ |
| K853245 | TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER | Tracor Instruments, Inc. | 1985-10-16 | Traditional | PDF ↗ |
| K851392 | TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200 | Tracor Instruments, Inc. | 1985-06-20 | Traditional | PDF ↗ |
| K851015 | TA-20 AUTOMATIC INDUSTIRAL AUDIOMETER | Teledyne Avionics Div. of Teledyne | 1985-06-04 | Traditional | PDF ↗ |
| K845050 | UP800 A UNIVERSAL PRINTER | Madsen Electronics (Canada) , Ltd. | 1985-05-29 | Traditional | PDF ↗ |
| K843618 | AUDIOMETER | Grason-Stadler, Inc. | 1984-12-03 | Traditional | PDF ↗ |
| K844069 | TA-201 CLINICAL AUDIOMETER | Teledyne Avionics Div. of Teledyne | 1984-12-03 | Traditional | PDF ↗ |
| K841167 | DEMLAR SYS I COMPUTER BASED AUDIOMETER | Demlar Medical, Inc. | 1984-06-27 | Traditional | PDF ↗ |
| K841567 | AUDIOMETER MA728 | Maico Hearing Instruments, Inc. | 1984-06-27 | Traditional | PDF ↗ |
| K833883 | DIGITAL AUDIOMETER/HEARING AID 3100 | Frye Electronics, Inc. | 1984-02-21 | Traditional | PDF ↗ |
| K831431 | AUDIOMETER MODEL-500 | Audimax | 1983-06-30 | Traditional | PDF ↗ |
Product code EWO · Class II · Ear, Nose, Throat. Data: openFDA.