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 12 of 14
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K832081 | PHONIC EAR PE 845PPC-D | Phonic Ear, Inc. | 1983-08-01 | Traditional | PDF ↗ |
| K832129 | HEARING AID G3H & G3T | Widex Hearing Aid Co., Inc. | 1983-07-26 | Traditional | PDF ↗ |
| K830790 | PERSONAL AMPLIFIER MODULE | Electone, Inc. | 1983-07-12 | Traditional | PDF ↗ |
| K831721 | RIONET HEARING AID -AND/OR RION | Rion Acoustic Instruments, Inc. | 1983-07-07 | Traditional | PDF ↗ |
| K830960 | CUSTOM IN-THE-EAR HEARING AID | Finetone Hearing Instruments | 1983-06-30 | Traditional | PDF ↗ |
| K831197 | MODEL 343D HEARING AID | Telex Communications, Inc. | 1983-05-09 | Traditional | PDF ↗ |
| K830465 | WIDEX HEARING AID #G2H & G2T | Widex Hearing Aid Co., Inc. | 1983-05-09 | Traditional | PDF ↗ |
| K831217 | MODEL BERNAFON T-86 | Bernafon, Inc. | 1983-05-09 | Traditional | PDF ↗ |
| K823588 | PERSONAL ROMEAR | Romear Mfg., Inc. | 1983-04-27 | Traditional | PDF ↗ |
| K823788 | MECON I | Mecon Labs | 1983-03-29 | Traditional | PDF ↗ |
| K830236 | RIONET HEARING AID | Rion Acoustic Instruments, Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K830436 | OTICON, E-27P | Octicon Corp. | 1983-03-10 | Traditional | PDF ↗ |
| K830435 | OTICON, E25P | Octicon Corp. | 1983-03-10 | Traditional | PDF ↗ |
| K830459 | BEHIND THE EAR HEARING AID OMNI #OS | Omni Hearing Systems | 1983-03-07 | Traditional | PDF ↗ |
| K830402 | HEARING AID, #UE7-D | Unitron Industries, Inc. | 1983-03-07 | Traditional | PDF ↗ |
| K830303 | 800 BLUE | Electone, Inc. | 1983-03-07 | Traditional | PDF ↗ |
| K830098 | PHONIC EAR | Phonic Ear, Inc. | 1983-02-01 | Traditional | PDF ↗ |
| K823067 | MODEL F1 HEARING AID | Katz Hearing Aid Center | 1983-02-01 | Traditional | PDF ↗ |
| K823847 | RIONET HEARING AID HB-69CI | Rion Acoustic Instruments, Inc. | 1983-01-21 | Traditional | PDF ↗ |
| K823089 | RCI EARMATE | Rci, Inc. | 1983-01-21 | Traditional | PDF ↗ |
| K823803 | RIONET HEARING AID HB-32P | Rion Acoustic Instruments, Inc. | 1983-01-21 | Traditional | PDF ↗ |
| K823244 | TECH. CLARATRON & INDUSTRIAL AMPLIFIER | Longview Hearing Aid Center | 1983-01-17 | Traditional | PDF ↗ |
| K823073 | 101M IN-THE-EAR | Danavox, Inc. | 1983-01-07 | Traditional | PDF ↗ |
| K823178 | TEL-STAR NU-WAY & GENERIC E | Omni Hearing Systems | 1983-01-07 | Traditional | PDF ↗ |
| K823669 | HEARING AID UNITRON #UE4-H | Unitron Industries, Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K823531 | BEHIND-THE-EAR HEARING AID #8003 | Danavox, Inc. | 1982-12-15 | Traditional | PDF ↗ |
| K823384 | HEARING AID HB-72 RIONET | Kindel & Anderson | 1982-12-09 | Traditional | PDF ↗ |
| K823383 | HEARING AID HB-33 RIONET | Kindel & Anderson | 1982-12-09 | Traditional | PDF ↗ |
| K823431 | HEARING AID #G6H & G6T | Widex Hearing Aid Co., Inc. | 1982-12-03 | Traditional | PDF ↗ |
| K823460 | MODELS G6H, G6T, G1H & G1T | Widex Hearing Aid Co., Inc. | 1982-12-03 | Traditional | PDF ↗ |
| K823468 | MODEL H 37E | Marcon Hearing Instruments, Inc. | 1982-12-03 | Traditional | PDF ↗ |
| K823285 | MODEL WHO1 HEARING AID | Panasonic Co. Div. Matsu Elec. Corp. America | 1982-11-29 | Traditional | PDF ↗ |
| K823366 | HEARING AID UE-10-H | Unitron Industries, Inc. | 1982-11-29 | Traditional | PDF ↗ |
| K823365 | HEARING AID UE-10 | Unitron Industries, Inc. | 1982-11-22 | Traditional | PDF ↗ |
| K822805 | HEARING AID, UNITRON MODEL UE7 | Unitron Industries, Inc. | 1982-10-13 | Traditional | PDF ↗ |
| K822779 | PHONIC EAR-PE 845-PPC | Phonic Ear, Inc. | 1982-10-04 | Traditional | PDF ↗ |
| K822579 | BOSCH STAR 66F-SP HEARING AID | Bosch Hearing Instruments, Inc. | 1982-09-30 | Traditional | PDF ↗ |
| K822619 | BEHIND-THE-EAR MODEL 115PPPCW | Danavox, Inc. | 1982-09-14 | Traditional | PDF ↗ |
| K822655 | BEHIND-THE-EAR MODEL 115 V AGC O W | Danavox, Inc. | 1982-09-14 | Traditional | PDF ↗ |
| K822506 | HEARING AID, UNITRON UE3-D/DN | Unitron Industries, Inc. | 1982-09-07 | Traditional | PDF ↗ |
| K821987 | EARETTE HEARING AID OPTICON MODEL E28P | Oticon Corp. | 1982-08-19 | Traditional | PDF ↗ |
| K822387 | BEHIND-THE-EAR MODEL SERIES 123 | Danavox, Inc. | 1982-08-19 | Traditional | PDF ↗ |
| K821991 | DANAVOS CUSTOM EAR | Deravox, Inc. | 1982-08-12 | Traditional | PDF ↗ |
| K822163 | ENT RETRACTORS | Kelleher Corp. | 1982-08-11 | Traditional | PDF ↗ |
| K821972 | HEARING AID VARIOUS MODELS | Panasonic Co. Div. Matsu Elec. Corp. America | 1982-07-20 | Traditional | PDF ↗ |
| K821899 | HEARING AID, UNITRON MODELS UE3/3-N | Unitron Industries, Inc. | 1982-07-14 | Traditional | PDF ↗ |
| K821900 | HEARING AID, UNITRON MODEL UE5 | Unitron Industries, Inc. | 1982-07-14 | Traditional | PDF ↗ |
| K821760 | SERIES M PUSH-PULL INPUT COMPRESSION | Maico Hearing Instruments, Inc. | 1982-06-25 | Traditional | PDF ↗ |
| K821550 | MODEL AH BEHING-THE-EAR-HEARING AID | Dahlberg Electronics, Inc. | 1982-06-14 | Traditional | PDF ↗ |
| K821447 | MODEL BERUAFON T85 & T95 | Beruafon, Inc. | 1982-06-09 | Traditional | PDF ↗ |
| K821325 | OTICON | Oticon Corp. | 1982-06-07 | Traditional | PDF ↗ |
| K821390 | CUSTOM, IN-THE-EAR HEARING AID | Ear-Tronics, Inc. | 1982-06-07 | Traditional | PDF ↗ |
| K821165 | SONIC MODEL 8711 HEARING AID | Spec Systems, Inc. | 1982-05-24 | Traditional | PDF ↗ |
| K821132 | MODEL 28C HEAPING AID | Telex Communications, Inc. | 1982-05-13 | Traditional | PDF ↗ |
| K821042 | MODEL IM9 | Marcon Hearing Instruments, Inc. | 1982-05-05 | Traditional | PDF ↗ |
| K820993 | AUDIO-ADI, AA SERIES | Audio-Aid, Inc. | 1982-05-05 | Traditional | PDF ↗ |
| K820833 | AUDICRAFT VIP HEARING AID | Audina Hearing Instrument | 1982-04-09 | Traditional | PDF ↗ |
| K820656 | RIONET HEARING AID HA-57 | Rion Acoustic Instruments, Inc. | 1982-04-09 | Traditional | PDF ↗ |
| K820185 | RELINER FOR HEARING AID EARMOLDS | Aid-To-Hearing Corp. | 1982-04-09 | Traditional | PDF ↗ |
| K820488 | CHAMPION - HEARING AID | Electrone, Inc. | 1982-03-19 | Traditional | PDF ↗ |
| K820445 | HEARING AID | Sage Electronics Products, Inc. | 1982-03-11 | Traditional | PDF ↗ |
| K820425 | OTOMET MODEL M-9 HEARING INSTRUMENT | Otomet Corp. | 1982-03-02 | Traditional | PDF ↗ |
| K820398 | DAHLBERG HEARING AID MODEL AL | Dahlberg Electronics, Inc. | 1982-03-02 | Traditional | PDF ↗ |
| K820349 | RIONET HEARING AID HB-71H | Rion Acoustic Instruments, Inc. | 1982-03-01 | Traditional | PDF ↗ |
| K820350 | RIONET HEARING AID HB-71S | Rion Acoustic Instruments, Inc. | 1982-03-01 | Traditional | PDF ↗ |
| K820348 | RIONET HEARING AID HB-69AS | Rion Acoustic Instruments, Inc. | 1982-03-01 | Traditional | PDF ↗ |
| K820172 | PHONIC EAR MODEL PE 810S | Phonic Ear, Inc. | 1982-02-24 | Traditional | PDF ↗ |
| K820148 | MODEL 343 HEARING AID | Telex Communications, Inc. | 1982-02-23 | Traditional | PDF ↗ |
| K820041 | BOSCH TOP STAR III | Bosch Hearing Instruments, Inc. | 1982-01-22 | Traditional | PDF ↗ |
| K813330 | POST-AURICULAR HEARING AID MODEL S-101 | Telesonic, Inc. | 1982-01-19 | Traditional | PDF ↗ |
| K813329 | POST-AURICULAR HEARING AID MODEL P-101 | Telesonic, Inc. | 1982-01-19 | Traditional | PDF ↗ |
| K813583 | PHONIC EAR MODEL PE805CD | Phonic Ear, Inc. | 1982-01-12 | Traditional | PDF ↗ |
| K813546 | RIONET HEARING AID HI-62 | Rion Acoustic Instruments, Inc. | 1982-01-12 | Traditional | PDF ↗ |
| K813344 | POST-AURICULAR HEARING AID MODEL ASP-103 | Telesonic, Inc. | 1981-12-31 | Traditional | PDF ↗ |
| K813316 | CUSTOM-IN-THE-EAR HEARING AID | Telesonic, Inc. | 1981-12-31 | Traditional | PDF ↗ |
| K813206 | HEARING AID CUSTOM ITE | Duvan Acoustics, Inc. | 1981-12-08 | Traditional | PDF ↗ |
| K813229 | HEARING AID MODEL UE9-R | Unitron Industries, Inc. | 1981-12-08 | Traditional | PDF ↗ |
| K813249 | HELP-MATE | G & W Applied Science Laboratories | 1981-12-03 | Traditional | PDF ↗ |
| K812937 | BEHIND-THE-EAR MODEL 115 | Danavox, Inc. | 1981-11-06 | Traditional | PDF ↗ |
| K812938 | IN-THE-EAR MODEL 821 | Danavox, Inc. | 1981-11-06 | Traditional | PDF ↗ |
| K812939 | IN-THE-EAR MODEL 101M | Danavox, Inc. | 1981-11-06 | Traditional | PDF ↗ |
| K812578 | ELEGANCE | Qualitone | 1981-10-02 | Traditional | PDF ↗ |
| K811988 | EAGLE I HEARING AID | Electone, Inc. | 1981-07-28 | Traditional | PDF ↗ |
| K811719 | CUSTOM IN-THE-EAR HEARING AID | Hearing Health Group, Inc. | 1981-07-27 | Traditional | PDF ↗ |
| K811751 | FINETONE MODEL VI HEARING AID | Vicon Instrument Co. | 1981-07-15 | Traditional | PDF ↗ |
| K811578 | DAHLBERG MODEL AP HEARING AID | Dahlberg Electronics, Inc. | 1981-07-01 | Traditional | PDF ↗ |
| K811031 | TELESONIC & ARCON | Telesonic, Inc. | 1981-07-01 | Traditional | PDF ↗ |
| K811529 | RIONET HEARING AID HB-69S | Rion Acoustic Instruments, Inc. | 1981-06-26 | Traditional | PDF ↗ |
| K811531 | RIONET HEARING AID HB-69 | Rion Acoustic Instruments, Inc. | 1981-06-26 | Traditional | PDF ↗ |
| K811522 | RE-HP SERIES HEARING AIDS | Radioear Corp. | 1981-06-26 | Traditional | PDF ↗ |
| K811530 | RIONET HEARING AID HB 69 T | Rion Acoustic Instruments, Inc. | 1981-06-26 | Traditional | PDF ↗ |
| K811286 | HEARING AID MODEL E1-PL | Unitron Industries, Inc. | 1981-06-16 | Traditional | PDF ↗ |
| K811285 | HEARING AID MODEL E1-P | Unitron Industries, Inc. | 1981-06-16 | Traditional | PDF ↗ |
| K811344 | BEHIND-THE-EAR HEARING AID | Maico Hearing Instruments, Inc. | 1981-06-16 | Traditional | PDF ↗ |
| K811158 | OMNI | Omni Hearing Systems | 1981-05-27 | Traditional | PDF ↗ |
| K811226 | DAHLBERG MODEL AM | Dahlberg Electronics, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K811174 | HEARING AID, UNITRON MODEL C5-H | Unitron Industries, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K810986 | EARETTE HEARING AID OTICON #E25F | Oticon Corp. | 1981-05-05 | Traditional | PDF ↗ |
| K810987 | EARETTE HEARING AID OTICON #E27F | Oticon Corp. | 1981-05-05 | Traditional | PDF ↗ |
| K810577 | POWER SONIC | Qualitone | 1981-03-31 | Traditional | PDF ↗ |
Product code ESD · Class I · Ear, Nose, Throat. Data: openFDA.