FDA Product Code
FDA Product Code ESD — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3300
510(k) Clearances — 1,367 records · page 14 of 14
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K790095 | MODULE PERSONAL EAR (DELUXE) | Qualitone | 1979-01-26 | Traditional | PDF ↗ |
| K790094 | MODULE PERSONAL EAR (COMPRESSION) | Qualitone | 1979-01-26 | Traditional | PDF ↗ |
| K782122 | HEARING AID, MODEL AA | Dahlberg Electronics, Inc. | 1979-01-22 | Traditional | PDF ↗ |
| K782121 | HEARING AID, MODEL GB | Dahlberg Electronics, Inc. | 1979-01-22 | Traditional | PDF ↗ |
| K782053 | HEARING AID, POST-AURICULAR | Hc Electronics | 1978-12-15 | Traditional | PDF ↗ |
| K781881 | HEARING AID, MODEL 781 | Danavox, Inc. | 1978-11-15 | Traditional | PDF ↗ |
| K781663 | HEARING AID, ITE MODULAR MODEL I, II, V | Oticon Corp. | 1978-10-10 | Traditional | PDF ↗ |
| K781595 | BODY-WORN HEARING AID, MODEL 787PP | Danavox, Inc. | 1978-09-27 | Traditional | PDF ↗ |
| K781596 | HEARING AID, MODEL 775 PP/AGC | Danavox, Inc. | 1978-09-27 | Traditional | PDF ↗ |
| K781513 | HEARING AID, UNITRON MODEL 960PL | Unitron Industries, Inc. | 1978-09-14 | Traditional | PDF ↗ |
| K781502 | HEARING AID, UNITRON MODEL 761P | Unitron Industries, Inc. | 1978-09-11 | Traditional | PDF ↗ |
| K781458 | RADIOEAR RE SERIES HEARING AIDS | Radioear Corp. | 1978-09-07 | Traditional | PDF ↗ |
| K781439 | HEARING AID, UNITRON MODEL 958 | Unitron Industries, Inc. | 1978-08-31 | Traditional | PDF ↗ |
| K781434 | HEARING AID, UNITRON MODEL 975 | Unitron Industries, Inc. | 1978-08-31 | Traditional | PDF ↗ |
| K781212 | HEARING AID, MODEL 783DU | Danavox, Inc. | 1978-08-14 | Traditional | PDF ↗ |
| K781094 | HEARING AID, EYEGLASS | Argosy Intl. (Usa), Inc. | 1978-07-17 | Traditional | PDF ↗ |
| K781096 | HEARING AID, EYEGLASS, B-12 | Argosy Intl. (Usa), Inc. | 1978-07-17 | Traditional | PDF ↗ |
| K781095 | HEARING AID, BEHIND THE EAR | Argosy Intl. (Usa), Inc. | 1978-07-17 | Traditional | PDF ↗ |
| K781033 | HEARING AID | Phonemics, Inc. | 1978-06-28 | Traditional | PDF ↗ |
| K780921 | MM-CE DM (BEHIND THE EAR) | Argosy Intl. (Usa), Inc. | 1978-06-14 | Traditional | PDF ↗ |
| K780915 | 780 SE (BEHIND THE EAR) | Argosy Intl. (Usa), Inc. | 1978-06-14 | Traditional | PDF ↗ |
| K780922 | UM VII (BEHIND THE EAR) | Argosy Intl. (Usa), Inc. | 1978-06-14 | Traditional | PDF ↗ |
| K780919 | M25 PP (BEHIND THE EAR) | Argosy Intl. (Usa), Inc. | 1978-06-14 | Traditional | PDF ↗ |
| K780917 | PRIMO CE (BEHIND THE EAR) | Argosy Intl. (Usa), Inc. | 1978-06-14 | Traditional | PDF ↗ |
| K780914 | PM 25 PP (BODY AID) | Argosy Intl. (Usa), Inc. | 1978-06-14 | Traditional | PDF ↗ |
| K780916 | 780 UE (BEHIND THE EAR) | Argosy Intl. (Usa), Inc. | 1978-06-14 | Traditional | PDF ↗ |
| K780920 | MM-CE 11 (BEHIND THE EAR) | Argosy Intl. (Usa), Inc. | 1978-06-14 | Traditional | PDF ↗ |
| K780918 | PRIMO CEDM (BEHIND THE EAR) | Argosy Intl. (Usa), Inc. | 1978-06-14 | Traditional | PDF ↗ |
| K780820 | HEARING AID MODEL 8148 | Int'L Hearing Aids, Inc. | 1978-05-31 | Traditional | PDF ↗ |
| K780822 | HEARING AID MODEL 8160U | Int'L Hearing Aids, Inc. | 1978-05-31 | Traditional | PDF ↗ |
| K780821 | HEARING AID MODEL 8160H | Int'L Hearing Aids, Inc. | 1978-05-31 | Traditional | PDF ↗ |
| K780694 | HEARING AID BATTERY CHARGER | Cahill Enterprises, Inc. | 1978-05-12 | Traditional | PDF ↗ |
| K780667 | HEARING AID-MODEL 2010 | Radioear Corp. | 1978-05-03 | Traditional | PDF ↗ |
| K780699 | EARETTE HEARING AID | Opticon Corp. | 1978-05-03 | Traditional | PDF ↗ |
| K780669 | HEATING AIDS-MODEL C78A & C78B | Circle Hearing Instruments, Inc. | 1978-05-03 | Traditional | PDF ↗ |
| K780654 | HEARING AID, EARETTE | Oticon Corp. | 1978-04-28 | Traditional | PDF ↗ |
| K780459 | CLEARTONE MODEL-1 & 2 HEARING AIDS | Cleartone Custom Hearing Instruments | 1978-03-30 | Traditional | PDF ↗ |
| K780363 | PHONIC EAR | Hc Electronics | 1978-03-21 | Traditional | PDF ↗ |
| K780309 | IN-THE-EAR HEARING AID, MODEL CE-3 | Starkey Laboratories, Inc. | 1978-02-28 | Traditional | PDF ↗ |
| K780197 | HEARING AID, BODY WORN | Oticon Corp. | 1978-02-21 | Traditional | PDF ↗ |
| K780241 | COMPRESSION MULTISONIC | Qualitone | 1978-02-17 | Traditional | PDF ↗ |
| K780067 | HEARING AID, BEHIND-THE-EAR | Maico Hearing Instruments, Inc. | 1978-01-20 | Traditional | PDF ↗ |
| K772201 | HEARING AID, BODY TYPE, MODEL H | Maico Hearing Instruments, Inc. | 1977-12-20 | Traditional | PDF ↗ |
| K772101 | HEARING AID-MODEL PE-1 | Starkey Laboratories, Inc. | 1977-11-21 | Traditional | PDF ↗ |
| K772100 | HEARING AID-MODEL CE-2 | Starkey Laboratories, Inc. | 1977-11-21 | Traditional | PDF ↗ |
| K771762 | MODULAR HEARING DEVICE, MODEL S291 | Vicon Instrument Co. | 1977-10-04 | Traditional | PDF ↗ |
| K771607 | HEARING AID MODEL 775 | Danavox, Inc. | 1977-08-25 | Traditional | PDF ↗ |
| K771356 | POST-AURICULAR HEARING AID HC 880 | Hc Electronics | 1977-07-29 | Traditional | PDF ↗ |
| K771069 | MULTISONIC (SUPER) CODE TSM | Qualitone | 1977-06-24 | Traditional | PDF ↗ |
| K771029 | MULTISONIC (DELUXE) CODE TDM | Qualitone | 1977-06-22 | Traditional | PDF ↗ |
| K770960 | HEARING AID, SERIES R | Maico Hearing Instruments, Inc. | 1977-06-14 | Traditional | PDF ↗ |
| K770885 | HEARING AID, SERIES K-BEHIND-THE-EAR | Maico Hearing Instruments, Inc. | 1977-05-25 | Traditional | PDF ↗ |
| K770689 | HEARING AID MODEL A8H AND A8T | Widex Hearing Aid Co., Inc. | 1977-04-20 | Traditional | PDF ↗ |
| K770688 | HEARING AID MODEL F8H ANL F8T | Widex Hearing Aid Co., Inc. | 1977-04-20 | Traditional | PDF ↗ |
| K770373 | HEARING AID, MAICO DB-POWER | Maico Hearing Instruments, Inc. | 1977-03-02 | Traditional | PDF ↗ |
| K770309 | HEARING AID, DM IROS | Maico Hearing Instruments, Inc. | 1977-02-28 | Traditional | PDF ↗ |
| K770360 | HEARING AID, MAICO DM MARK 180 | Maico Hearing Instruments, Inc. | 1977-02-28 | Traditional | PDF ↗ |
| K770308 | HEARING AID, DM IROS DIRECTIONAL | Maico Hearing Instruments, Inc. | 1977-02-28 | Traditional | PDF ↗ |
| K770321 | PERCEPTOR | Danavox, Inc. | 1977-02-28 | Traditional | PDF ↗ |
| K761216 | HEARING AIDS (MODEL E-552 S-712) | Vicon Instrument Co. | 1976-12-16 | Traditional | PDF ↗ |
| K761223 | WIDEX HEARING AID MODEL F8 | Widex Hearing Aid Co., Inc. | 1976-12-16 | Traditional | PDF ↗ |
| K761103 | WIDEX HEARING AID MODEL F7H & F7T | Widex Hearing Aid Co., Inc. | 1976-12-02 | Traditional | PDF ↗ |
| K760996 | HEARING AID (MODEL 695D, 905 & 960P) | Unitron Industries, Inc. | 1976-11-16 | Traditional | PDF ↗ |
| K760887 | COMPRESSION ADJUSTRETTE | Qualitone | 1976-11-03 | Traditional | PDF ↗ |
| K760609 | EYEGLASS HEARING AID | Zenith Hearing Instrument Co. | 1976-09-21 | Traditional | PDF ↗ |
| K760244 | RADIOEAR, PERSONAL | Radioear Corp. | 1976-08-23 | Traditional | PDF ↗ |
| K760215 | HEARING AID, S-522 FM | Vicon Instrument Co. | 1976-07-21 | Traditional | PDF ↗ |
Product code ESD · Class I · Ear, Nose, Throat. Data: openFDA.