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 3 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K822335 | AUDIT | Axonics, Inc. | 1983-02-07 | Traditional | PDF ↗ |
| K823554 | ACOH WELLNESS TESTER | Occupational Health, Inc. | 1983-01-05 | Traditional | PDF ↗ |
| K822745 | THE SCREENING TYMPANOMETER | American Electromedics Corp. | 1982-09-30 | Traditional | PDF ↗ |
| K822414 | TRACOR RA400 AUDIOMETER | Tracor Instruments, Inc. | 1982-08-30 | Traditional | PDF ↗ |
| K820715 | MIDDLE EAR ANALYZER (IMPEDANCE AUDIO | Grason-Stadler, Inc. | 1982-04-09 | Traditional | PDF ↗ |
| K812529 | EARSCAN | Micro Audiometrics Corp. | 1981-10-14 | Traditional | PDF ↗ |
| K811727 | PORTABLE AUDIOMETERS | Maico Hearing Instruments, Inc. | 1981-07-15 | Traditional | PDF ↗ |
| K810583 | AUDIOMETER | Grason-Stadler, Inc. | 1981-04-29 | Traditional | PDF ↗ |
| K810537 | AUTOMATIC SCREENING AUDIOMETER | Positron | 1981-03-11 | Traditional | PDF ↗ |
| K803072 | HIGH FREQUENCY AUDIOMETER DELMAR #20-K | Demlar Medical, Inc. | 1980-12-30 | Traditional | PDF ↗ |
| K802963 | 101, 151, 161 PORTABLE AUDIOMETERS | Amplaid USA, Inc. | 1980-12-19 | Traditional | PDF ↗ |
| K802560 | TINNITUS RESEARCH AUDIOMETER | Starkey Laboratories, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K802350 | ATTENU-CHEK | Hear Co., Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K802207 | RION DIAGNOSTIC AUDIOMETER | Rion Acoustic Instruments, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K801325 | CLINICAL AUDIOMETER MODEL TA-200 | Teledyne Avionics Div. of Teledyne | 1980-06-30 | Traditional | PDF ↗ |
| K791467 | TA-10 PORTABLE SCREENING AUDIOMETER | Teledyne Avionics Div. of Teledyne | 1979-09-28 | Traditional | PDF ↗ |
| K790878 | SCREENING AUDIOMETER, HIGH FREQUENCY | Vicon Instrument Co. | 1979-08-03 | Traditional | PDF ↗ |
| K791170 | MIS AURAL ACOUSTIC SCREENER | Maico Hearing Instruments, Inc. | 1979-06-25 | Traditional | PDF ↗ |
| K790903 | TRACOR MODEL RA-411 MICROPROCESSOR | Tracor Instruments, Inc. | 1979-05-31 | Traditional | PDF ↗ |
| K790846 | MIDDLE EAR ANALYZER (IMPED. AUDIOMTR) | Grason-Stadler, Inc. | 1979-05-17 | Traditional | PDF ↗ |
| K790609 | AUDIOMETER | Grason-Stadler, Inc. | 1979-04-10 | Traditional | PDF ↗ |
| K781474 | PREAMPLIFIER MODELS 8101PI & 8102PI | Life-Tech Instruments, Inc. | 1978-09-07 | Traditional | PDF ↗ |
| K780749 | SPEECH AUDIOMETER RA 226 | Tracor Instruments, Inc. | 1978-05-16 | Traditional | PDF ↗ |
| K780450 | TRACOR RA 410 AUDIOMETER | Tracor Instruments, Inc. | 1978-03-30 | Traditional | PDF ↗ |
| K780382 | AUDIOMETER, PORTABLE, AIR CONDUCTION | Maico Hearing Instruments, Inc. | 1978-03-14 | Traditional | PDF ↗ |
| K780269 | COMPUTER AUDIOMETER - MA25 | Maico Hearing Instruments, Inc. | 1978-02-27 | Traditional | PDF ↗ |
| K780270 | COMPUTER AUDIOMETER - MA26 | Maico Hearing Instruments, Inc. | 1978-02-27 | Traditional | PDF ↗ |
| K780150 | NEONATAL SCREENING AUDIOMETER | Telediagnostic Systems, Inc. | 1978-02-13 | Traditional | PDF ↗ |
| K772169 | AUDIOMETER, RECORDING, AUTOMATIC | B&K Instruments, Inc. | 1977-12-02 | Traditional | PDF ↗ |
| K770823 | AUDIOMETRIC TESTING SYS., SERIES 500 | Automated Testing Services, Ltd. | 1977-05-18 | Traditional | PDF ↗ |
| K770618 | AUDIOMETER, MA31 | Maico Hearing Instruments, Inc. | 1977-04-08 | Traditional | PDF ↗ |
| K770616 | AUDIOMETER, MA29, PURE TONE AIR CONDUCT. | Maico Hearing Instruments, Inc. | 1977-04-08 | Traditional | PDF ↗ |
| K770617 | AUDIOMETER, MA30, AIR & BONE CONDUCTION | Maico Hearing Instruments, Inc. | 1977-04-07 | Traditional | PDF ↗ |
| K770553 | AUDIOMETER, DIAG., ADVANCED, MA-22 | Maico Hearing Instruments, Inc. | 1977-03-24 | Traditional | PDF ↗ |
| K760859 | TRACOR MODEL RA 208 COMPLIANCE AUDIOM | Tracor Instruments, Inc. | 1976-10-29 | Traditional | PDF ↗ |
Product code EWO · Class II · Ear, Nose, Throat. Data: openFDA.