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 11 of 14
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K852690 | HEARING AID, UNITRON MODEL UM60-H | Unitron Industries, Inc. | 1985-07-31 | Traditional | PDF ↗ |
| K851866 | DAHLBERG MODEL DB BEHIND-THE-EAR HEARING AID | Miracle-Ear/Dahlberg, Inc. | 1985-07-05 | Traditional | PDF ↗ |
| K851869 | DAHLBERG MODEL DC BEHIND-THE-EAR HEARING AID | Miracle-Ear/Dahlberg, Inc. | 1985-07-05 | Traditional | PDF ↗ |
| K851867 | DAHLBERG MODEL DD BEHING-THE-EAR HEARING AID | Miracle-Ear/Dahlberg, Inc. | 1985-07-05 | Traditional | PDF ↗ |
| K851810 | MODEL DA BEHIND-THE-EAR HEARING AID | Miracle-Ear/Dahlberg, Inc. | 1985-07-05 | Traditional | PDF ↗ |
| K851427 | HEARING AID(ALL IN THE EAR) | Woodard Hearing Aid Center | 1985-07-01 | Traditional | PDF ↗ |
| K851868 | DAHLBERT MODEL DE BEHING-THE-EAR HEARING AID | Miracle-Ear/Dahlberg, Inc. | 1985-07-01 | Traditional | PDF ↗ |
| K850980 | CRESTLINE CL IN-THE-EAR HEARING AID | Dahlberg Electronics, Inc. | 1985-06-19 | Traditional | PDF ↗ |
| K850914 | HEARING AID, UNITRON MODEL UC | Unitron Industries, Inc. | 1985-06-05 | Traditional | PDF ↗ |
| K851069 | BODY TYPE HEARING AID 107S | Danavox, Inc. | 1985-06-05 | Traditional | PDF ↗ |
| K851970 | QUALITONE STOCK CANAL AID | Qualitone | 1985-06-04 | Traditional | PDF ↗ |
| K850981 | CRESTLINE CB BEHIND-THE-EAR HEARING AID | Dahlberg Electronics, Inc. | 1985-05-31 | Traditional | PDF ↗ |
| K851430 | EARETTE HEARING AID(BEHIND THE EAR OTICON E37F | Oticon Corp. | 1985-05-29 | Traditional | PDF ↗ |
| K851429 | EARETTE HEARING AID(BEHIND THE EAR OTICON E35F | Oticon Corp. | 1985-05-29 | Traditional | PDF ↗ |
| K851547 | BEHIND THE EAR HEARING AID MODEL BERNAFON T-82 | Bernafon, Inc. | 1985-05-29 | Traditional | PDF ↗ |
| K850188 | BOSCH IN THE EAR HEARING AID SUPERSTAR | Robert Bosch Corp. | 1985-04-09 | Traditional | PDF ↗ |
| K844862 | POST-AURICULAR HEARING AID MODEL PE 600PPCH | Phonic Ear, Inc. | 1985-04-08 | Traditional | PDF ↗ |
| K844859 | POST-AURICULAR HEARING AID MODEL PE 600 PPC | Phonic Ear, Inc. | 1985-03-28 | Traditional | PDF ↗ |
| K844863 | POST-SURICULAR HEARING AID PE 600CD | Phonic Ear, Inc. | 1985-03-28 | Traditional | PDF ↗ |
| K844861 | POST-AURICULAR HEARING AID MODEL PE 600PPCL | Phonic Ear, Inc. | 1985-03-27 | Traditional | PDF ↗ |
| K844860 | POST-AURICULAR HEARING AID MODEL PE 600CHD | Phonic Ear, Inc. | 1985-03-27 | Traditional | PDF ↗ |
| K850190 | STAR 66F-AGC-I HEARING AID | Robert Bosch Corp. | 1985-03-25 | Traditional | PDF ↗ |
| K850187 | BOSCH STARR 66PP -HEARING AIDS | Robert Bosch Corp. | 1985-03-25 | Traditional | PDF ↗ |
| K850185 | BODY HEARING AIDS MT 80 SP | Robert Bosch Corp. | 1985-03-25 | Traditional | PDF ↗ |
| K850189 | BOSCH STAR 66PP-S HEARING AID | Robert Bosch Corp. | 1985-03-25 | Traditional | PDF ↗ |
| K850243 | HEARING AID 365 | Telex Communications, Inc. | 1985-03-25 | Traditional | PDF ↗ |
| K850763 | EARETTE HEARING AID OTICON E32U | Oticon Corp. | 1985-03-25 | Traditional | PDF ↗ |
| K850762 | EARETTE HEARING AID OTICON MODEL E32S | Oticon Corp. | 1985-03-25 | Traditional | PDF ↗ |
| K850123 | IN-TH-EAR HEARING AID | General Hearing Instruments, Inc. | 1985-03-21 | Traditional | PDF ↗ |
| K844093 | JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR | Jcm Labs, Inc. | 1985-01-29 | Traditional | PDF ↗ |
| K843484 | MECON X (TEN) | Mecon Labs | 1985-01-23 | Traditional | PDF ↗ |
| K843246 | HEARING AID, UNITRON UE12-PPL | Unitron Industries, Inc. | 1985-01-23 | Traditional | PDF ↗ |
| K844728 | ADVANCED HEARING INSTRUMENTS - HEARING AIDS | Advanced Hearing Instruments | 1985-01-23 | Traditional | PDF ↗ |
| K844985 | IN THE EAR MODEL X-ITE 84 | Bernafon, Inc. | 1985-01-23 | Traditional | PDF ↗ |
| K843245 | HEARING AID, UNITRON UE12-PP | Unitron Industries, Inc. | 1985-01-10 | Traditional | PDF ↗ |
| K844621 | BEHIND THE EAR HEARING AID BERNAFON T-88P | Bernafon, Inc. | 1985-01-07 | Traditional | PDF ↗ |
| K844648 | MODEL 363C HEARING AID | Telex Communications, Inc. | 1985-01-07 | Traditional | PDF ↗ |
| K844425 | BEHIND THE EAR HEARING AIDS BERNAFON X-13 | Bernafon, Inc. | 1985-01-04 | Traditional | PDF ↗ |
| K843789 | ULTRA & ULTRA MINATURE | Qualitone | 1984-12-13 | Traditional | PDF ↗ |
| K843574 | HEARING AID - ALL IN THE EAR | Auralogics Lab | 1984-12-11 | Traditional | PDF ↗ |
| K843068 | HEARING AIDS 372 & 372 AI | Telex Communications, Inc. | 1984-12-03 | Traditional | PDF ↗ |
| K844059 | RIONET HEARING AID HB-34AS | Rion Acoustic Instruments, Inc. | 1984-12-03 | Traditional | PDF ↗ |
| K843980 | PERSONAL AMPLIFIER SILENCER | Electone, Inc. | 1984-11-16 | Traditional | PDF ↗ |
| K842832 | A.S.P.C./CLEARSOUND | Asl, Inc. | 1984-11-09 | Traditional | PDF ↗ |
| K843791 | BEHIND-THE-EAR 123 VTH | Danavox, Inc. | 1984-11-09 | Traditional | PDF ↗ |
| K844000 | RIONET HEARING AID HB-73 | Rion Acoustic Instruments, Inc. | 1984-11-09 | Traditional | PDF ↗ |
| K843921 | IN THE CANAL HEARING AID RC, REDICANAL | Omni Hearing Systems | 1984-11-01 | Traditional | PDF ↗ |
| K841934 | RADIOEAR M430 PP | Radioear Corp. | 1984-09-07 | Traditional | PDF ↗ |
| K843144 | K-BASS LO FREQUENCY HEARING AID | Etymotic Research | 1984-09-07 | Traditional | PDF ↗ |
| K842546 | CUSTOM CANAL HEARING AID X-CITE 84 | Bernafon, Inc. | 1984-09-05 | Traditional | PDF ↗ |
| K842980 | IN-THE-EAR-CANAL HEARING AID | Ear Care Hearing Systems, Inc. | 1984-09-05 | Traditional | PDF ↗ |
| K843067 | TCA HEARING AID | Telex Communications, Inc. | 1984-09-05 | Traditional | PDF ↗ |
| K842875 | RIONET HEARING AID HB-35 | Rion Acoustic Instruments, Inc. | 1984-08-24 | Traditional | PDF ↗ |
| K842434 | BEHING THE EAR HEARING AID T-98 | Bernafon, Inc. | 1984-08-23 | Traditional | PDF ↗ |
| K842074 | EARETTE HEARING AID OTICON E30V | Oticon Corp. | 1984-08-23 | Traditional | PDF ↗ |
| K842073 | EARETTE HEARING AID OTICON E31V | Oticon Corp. | 1984-08-23 | Traditional | PDF ↗ |
| K841935 | RIONET HEARING AID HI-03 | Rion Acoustic Instruments, Inc. | 1984-08-14 | Traditional | PDF ↗ |
| K841933 | RADIOEAR M420H | Radioear Corp. | 1984-08-10 | Traditional | PDF ↗ |
| K840893 | CONFERETTE C2 | Siemens Hearing Instruments, Inc. | 1984-08-02 | Traditional | PDF ↗ |
| K841436 | OTICON E28A | Oticon Corp. | 1984-06-27 | Traditional | PDF ↗ |
| K841473 | HEARING AID MODEL 440PPC | Radioear Corp. | 1984-06-22 | Traditional | PDF ↗ |
| K833486 | IN-THE-EAR HEARING AID MODEL | Danavox, Inc. | 1984-06-22 | Traditional | PDF ↗ |
| K841475 | HEARING AID MODEL M400 | Radioear Corp. | 1984-06-22 | Traditional | PDF ↗ |
| K841474 | HEARING AID MODEL P500 | Radioear Corp. | 1984-06-22 | Traditional | PDF ↗ |
| K840906 | HEARING AID AUDIO-STARR A | Jade Electronics Corp. | 1984-05-16 | Traditional | PDF ↗ |
| K840891 | IN-THE-EAR HEARING AID RX10 & 20 | Audio-Aid, Inc. | 1984-05-10 | Traditional | PDF ↗ |
| K840728 | HEARING AIDS IN-THE-EAR | Hearing Instruments, Inc. | 1984-04-24 | Traditional | PDF ↗ |
| K840298 | MCA IN THE EAR CUSTOM HEARING AID | Maico Hearing Instruments, Inc. | 1984-04-17 | Traditional | PDF ↗ |
| K840165 | CANAL AID | Qualitone | 1984-04-03 | Traditional | PDF ↗ |
| K841012 | RIONET HEARING AID HB-71M | Rion Acoustic Instruments, Inc. | 1984-03-30 | Traditional | PDF ↗ |
| K840871 | BEHIND-THE-EAR HEARING AID 2000 | Telex Communications, Inc. | 1984-03-30 | Traditional | PDF ↗ |
| K840825 | SERIES MR IN-THE-EAR CUSTOM HEARING AID | Maico Hearing Instruments, Inc. | 1984-03-30 | Traditional | PDF ↗ |
| K833773 | CANAL HEARING AID | Siemens Hearing Instruments, Inc. | 1984-03-30 | Traditional | PDF ↗ |
| K840559 | IN-THE-EAR HEARING AID | Emtronics, Inc. | 1984-03-30 | Traditional | PDF ↗ |
| K840842 | HEARING AID UNITRON UE8 | Unitron Industries, Inc. | 1984-03-30 | Traditional | PDF ↗ |
| K840479 | BEHING-THE-EAR HEARING AID T-85D | Bernafon, Inc. | 1984-03-30 | Traditional | PDF ↗ |
| K840480 | BEHIND THE EAR HEARING AID T-97 | Bernafon, Inc. | 1984-03-30 | Traditional | PDF ↗ |
| K840359 | POST-AURICULAR HEARING AID | Phonic Ear, Inc. | 1984-02-21 | Traditional | PDF ↗ |
| K834523 | MODEL M410D HEARING AID | Radioear Corp. | 1984-02-10 | Traditional | PDF ↗ |
| K833926 | HEARING AID | Rion Acoustic Instruments, Inc. | 1983-12-19 | Traditional | PDF ↗ |
| K833803 | OTICON, E26P | Oticon Corp. | 1983-12-08 | Traditional | PDF ↗ |
| K833152 | METAVOX MV-1000 HEARING AID | Metavox, Inc. | 1983-12-08 | Traditional | PDF ↗ |
| K833775 | BEHIND-THE-EAR HEARING AIDS T-87 & | Bernafon, Inc. | 1983-12-08 | Traditional | PDF ↗ |
| K833333 | IN THE EAR HEARING AID OMNI 100 | Omni Hearing Systems | 1983-12-08 | Traditional | PDF ↗ |
| K832168 | PERSONAL AMPLIFIER | Electone, Inc. | 1983-11-21 | Traditional | PDF ↗ |
| K832633 | INNOVATIVE HEARING CORP. #IHC 1000 | Innovative Hearing Corp. | 1983-11-21 | Traditional | PDF ↗ |
| K833615 | HEARING AID UNITRON UI3 | Unitron Industries, Inc. | 1983-11-21 | Traditional | PDF ↗ |
| K833614 | HEARING AID, UNITRON UT1 | Unitron Industries, Inc. | 1983-11-21 | Traditional | PDF ↗ |
| K833334 | BEHIND THE EAR ASP-BB | Omni Hearing Systems | 1983-11-14 | Traditional | PDF ↗ |
| K833134 | RIONET HEARING AID HB-345 | Rion Acoustic Instruments, Inc. | 1983-11-14 | Traditional | PDF ↗ |
| K833510 | PANASONIC WH-50 HEARING AID | Panasonic Co. Div. Matsu Elec. Corp. America | 1983-11-14 | Traditional | PDF ↗ |
| K833451 | TEL-STAR NUWAY & GENERIC E ASP-BP | Omni Hearing Systems | 1983-11-14 | Traditional | PDF ↗ |
| K833073 | DAHLBERG #USS IN THE EAR HEARING AID | Dahlberg Electronics, Inc. | 1983-10-28 | Traditional | PDF ↗ |
| K832180 | REXTON RX10, RX20-30 & 40 | Rexton, Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K832326 | BEHIND-THE-EAR #123 AGCI | Danavox, Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K832751 | BEHIND-THE-EAR SERIES 125 | Danavox, Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K832701 | HSI ELITE #EC CUSTOM CANAL HEAR-AID | Hearing Services, Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K832376 | WIDEX HEARING AID MODEL L1 | Widex Hearing Aid Co., Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K831129 | HEARCO C | Hear Co., Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K831883 | HEARING AID UNITRON #UE8-D | Unitron Industries, Inc. | 1983-08-12 | Traditional | PDF ↗ |
Product code ESD · Class I · Ear, Nose, Throat. Data: openFDA.