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 6 of 14
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K923918 | IN-THE-EAR HEARING AID | Benway-Haworth-Lawlor Hearing Aids, Inc. | 1992-09-10 | Traditional | PDF ↗ |
| K923986 | CYBERNETIC OPTION (CYBER I) | Qualitone | 1992-09-10 | Traditional | PDF ↗ |
| K923784 | STARKEY SM SERIES BTE HEARING AIDS | Starkey Laboratories, Inc. | 1992-08-26 | Traditional | PDF ↗ |
| K923924 | VOICEWAVE | Personal Sound Technologies, Inc. | 1992-08-24 | Traditional | PDF ↗ |
| K923380 | SIEMENS MODEL TRITON 3004 B | Siemens Hearing Instruments, Inc. | 1992-08-18 | Traditional | PDF ↗ |
| K923379 | SIEMENS MODEL INFINITI 1001 B | Siemens Hearing Instruments, Inc. | 1992-08-18 | Traditional | PDF ↗ |
| K921725 | PHILIP XP SERIES, IN-THE CANAL HEARING AID | Philips Hearing Instruments Co. | 1992-08-11 | Traditional | PDF ↗ |
| K923388 | BTE HEARING AID OTICON MODEL: MULTIFOCUS POWER | Oticon Corp. | 1992-08-06 | Traditional | PDF ↗ |
| K923490 | BTE HEARING AID PERSONIC 410 | Oticon Corp. | 1992-08-06 | Traditional | PDF ↗ |
| K923491 | BTE HEARING AID PERSONIC 425 | Oticon Corp. | 1992-08-06 | Traditional | PDF ↗ |
| K923226 | EURION LOTOS PP HEARING AID | Eurion Hearing Instruments | 1992-07-30 | Traditional | PDF ↗ |
| K922392 | ITE, ITC, OE(OPEN), HS(HALF SHELL) HEARING AID | A-1 Hearing Aid Lab | 1992-07-10 | Traditional | PDF ↗ |
| K905555 | A-ZILICONE | Oticon Corp. | 1992-07-06 | Traditional | PDF ↗ |
| K922827 | OTOSONIC ACS K | Beltone Electronics Corp. | 1992-07-01 | Traditional | PDF ↗ |
| K922708 | WIDEX MODEL D32 | Widex Hearing Aid Co., Inc. | 1992-06-30 | Traditional | PDF ↗ |
| K922422 | PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES | Audioscience, Inc. | 1992-06-10 | Traditional | PDF ↗ |
| K915711 | IN THE EAR HEARING AID | Zenith-Omni H.C., Inc. | 1992-06-10 | Traditional | PDF ↗ |
| K922301 | BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL) | Beltone Electronics Corp. | 1992-06-10 | Traditional | PDF ↗ |
| K922224 | OTOSONIC ACS-IC | Beltone Electronics Corp. | 1992-05-27 | Traditional | PDF ↗ |
| K921463 | PHILIPS 31 SERIES IN THE EAR HEARING AID | Philips Hearing Instruments Co. | 1992-05-22 | Traditional | PDF ↗ |
| K922066 | TELEX MODEL 28A ITE CUSTOM HEARING AID | Telex Communications, Inc. | 1992-05-18 | Traditional | PDF ↗ |
| K922065 | TELEX MODEL M29 ITE CUSTOM HEARING AID | Telex Communications, Inc. | 1992-05-18 | Traditional | PDF ↗ |
| K921257 | EURION LOTOS P HEARING AID | Manro Corp. | 1992-05-15 | Traditional | PDF ↗ |
| K921656 | LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLE | Siemens Hearing Instruments, Inc. | 1992-05-08 | Traditional | PDF ↗ |
| K921829 | RIONET HEARING AID HB-52S | Authorized Hearing Systems, Inc. | 1992-04-29 | Traditional | PDF ↗ |
| K921830 | RIONET HEARING AID HB-52T | Authorized Hearing Systems, Inc. | 1992-04-28 | Traditional | PDF ↗ |
| K920911 | QCC CUSTOM CANAL AND QE1 ALL ITE | Qualitech Electronics, Inc. | 1992-04-27 | Traditional | PDF ↗ |
| K920657 | DI CUSTOM IN THE EAR AND IN THE CANAL | Dakota Laboratories, Inc. | 1992-03-31 | Traditional | PDF ↗ |
| K921122 | SOUNDCHOICE BTE | Bausch & Lomb, Inc. | 1992-03-30 | Traditional | PDF ↗ |
| K921023 | BELTONE OPRA CLEAR VOICE-K HEARING AID | Beltone Electronics Corp. | 1992-03-19 | Traditional | PDF ↗ |
| K920897 | RIONET HEARING AID - HB 52DU | Authorized Hearing Systems, Inc. | 1992-03-19 | Traditional | PDF ↗ |
| K912399 | HEARING AID (ALL-IN-THE-EAR) | Carlson'S Heritage Hearing Aid Center | 1992-03-12 | Traditional | PDF ↗ |
| K915794 | AD-HEAR | Hearing Components, Inc. | 1992-03-12 | Traditional | PDF ↗ |
| K920466 | EXTEND-EAR | Sonovation, Inc. Dba Avr Sonovation | 1992-02-27 | Traditional | PDF ↗ |
| K915450 | IN THE EAR HEARING AID | Zenith/Omni Hearing Instruments, Inc. | 1992-02-27 | Traditional | PDF ↗ |
| K920522 | RIONET HEARING AID HB-23M | Authorized Hearing Systems, Inc. | 1992-02-19 | Traditional | PDF ↗ |
| K920521 | RIONET HEARING AID HB-23T | Authorized Hearing Systems, Inc. | 1992-02-19 | Traditional | PDF ↗ |
| K914948 | AM 300 AGC-O | Electone, Inc. | 1992-02-19 | Traditional | PDF ↗ |
| K914947 | AM 300 XP | Electone, Inc. | 1992-02-18 | Traditional | PDF ↗ |
| K914798 | PREMIER CLASS D-ASP | Electone, Inc. | 1992-02-18 | Traditional | PDF ↗ |
| K914799 | PREMIER K-AMP | Electone, Inc. | 1992-02-18 | Traditional | PDF ↗ |
| K914797 | PREMIER CD RECHARGEABLE | Electone, Inc. | 1992-02-18 | Traditional | PDF ↗ |
| K914796 | PREMIER ASP/CD RECHARGEABLE | Electone, Inc. | 1992-02-18 | Traditional | PDF ↗ |
| K914795 | ELECTONE/PA RECHARGEABLE | Electone, Inc. | 1992-02-18 | Traditional | PDF ↗ |
| K920486 | RIONET HEARING AID HB-53P | Authorized Hearing Systems, Inc. | 1992-02-14 | Traditional | PDF ↗ |
| K920093 | AUDIOTONE MODEL A-96 | Miracle-Ear, Inc. | 1992-01-30 | Traditional | PDF ↗ |
| K920134 | PHILIPS 41 SERIES RAINBOW | Philips Int'L B.V. | 1992-01-24 | Traditional | PDF ↗ |
| K915614 | BTE HEARING AID MULTIFOCUS | Opticon Corp. | 1992-01-24 | Traditional | PDF ↗ |
| K920142 | PHILIPS M60 SERIES | Philips Int'L B.V. | 1992-01-23 | Traditional | PDF ↗ |
| K915346 | CUSTOM CANAL HEARING AID | Dicta Laboratories | 1992-01-15 | Traditional | PDF ↗ |
| K915875 | RIONET HEARING AID HB-71K (K-AMP) | Authorized Hearing Systems, Inc. | 1992-01-13 | Traditional | PDF ↗ |
| K914897 | SONOTONE BEHIND THE EAR MODEL ST 54-0 | Sonotone Intl., Inc. | 1992-01-10 | Traditional | PDF ↗ |
| K915519 | SONOTONE BEHIND THE EAR MODEL ST 53A | Sonotone Intl., Inc. | 1992-01-09 | Traditional | PDF ↗ |
| K914899 | SONOTONE BEHIND THE EAR MODEL ST 45G | Sonotone Hearing Instruments | 1992-01-09 | Traditional | PDF ↗ |
| K915684 | REXTON RX34 WITH HORIZON PROGRAMMABLE OPTION | Rexton, Inc. | 1992-01-09 | Traditional | PDF ↗ |
| K915683 | REXTON RX12 WITH HORIZON PROGRAMMABLE OPTION | Rexton, Inc. | 1992-01-09 | Traditional | PDF ↗ |
| K915076 | MED-EQUIP CORPORATION | Medequip Co. | 1992-01-09 | Traditional | PDF ↗ |
| K915517 | SONOTONE BODY AID MODEL ST 1000 BODY WORN | Sonotone Intl., Inc. | 1992-01-09 | Traditional | PDF ↗ |
| K915518 | SONOTONE BEHIND THE EAR MODEL ST 49 | Sonotone Intl., Inc. | 1992-01-09 | Traditional | PDF ↗ |
| K914898 | SONOTONE BEHIND THE EAR MODEL ST 47I | Sonotone Hearing Instruments | 1992-01-09 | Traditional | PDF ↗ |
| K915319 | RIONET HEARING AID HB-52AS | Rion Co. Ltd. Dba Rion Acoustic Device | 1992-01-09 | Traditional | PDF ↗ |
| K915461 | PHONAK 9000-AF ITE HEARING INSTRUMENT SERIES | Phonak, Inc. | 1991-12-30 | Traditional | PDF ↗ |
| K915252 | PHILIPS P74P BEHIND-THE-EAR HEARING AID | Philips Hearing Instruments Co. | 1991-12-05 | Traditional | PDF ↗ |
| K914982 | BELTONE PROFILE IN-THE-EAR HEARING AID | Beltone Electronics Corp. | 1991-11-27 | Traditional | PDF ↗ |
| K914981 | OTOSONIC (OSI) LPS IN-THE-EAR HEARING AID | Beltone Electronics Corp. | 1991-11-27 | Traditional | PDF ↗ |
| K914939 | OTOSONIC ACS-ASP | Beltone Electronics Corp. | 1991-11-22 | Traditional | PDF ↗ |
| K914940 | BELTONE CLEARVOICE | Beltone Electronics Corp. | 1991-11-22 | Traditional | PDF ↗ |
| K913366 | IN-THE-EAR HEARING AIDS | Fenwick Hearing Instruments | 1991-11-05 | Traditional | PDF ↗ |
| K914689 | HEARING AID, UNITRON MODEL VISTA 4000 | Unitron Industries, Inc. | 1991-11-05 | Traditional | PDF ↗ |
| K914688 | HEARING AID, UNITRON MODEL VISTA 3000 | Unitron Industries, Inc. | 1991-11-05 | Traditional | PDF ↗ |
| K914800 | P54 BTE HEARING AID | Philips Hearing Instruments Co. | 1991-11-05 | Traditional | PDF ↗ |
| K914477 | AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID | Miracle-Ear, Inc. | 1991-10-21 | Traditional | PDF ↗ |
| K914418 | ACT-II BEHIND THE EAR HEARING AID | Telex Communications, Inc. | 1991-10-21 | Traditional | PDF ↗ |
| K913245 | MODEL 80 HEARING AID DISPENSING SYSTEM | 3M Company | 1991-10-18 | Traditional | PDF ↗ |
| K914333 | SIEMENS MODEL LS-I W/INFINITI PROGRAMMABLE OPTION | Siemens Hearing Instruments, Inc. | 1991-10-11 | Traditional | PDF ↗ |
| K914017 | UC312, ULTRA MINIATURE ITC HEARING AID | Qualitone | 1991-09-23 | Traditional | PDF ↗ |
| K913592 | QUALITONE 46PP-AGC-I | Qualitone | 1991-09-18 | Traditional | PDF ↗ |
| K913781 | QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AID | Qualitone | 1991-09-18 | Traditional | PDF ↗ |
| K913771 | ELEGANCE - KED, BEHIND THE EAR HEARING AID | Qualitone | 1991-09-18 | Traditional | PDF ↗ |
| K913503 | PHONAK PICO-FORTE PP-C-P BTE HEARING INSTRUMENT | Phonak, Inc. | 1991-09-06 | Traditional | PDF ↗ |
| K913502 | PHONAK AUDINET PP-C-P BTE HEARING INSTRUMENT | Phonak, Inc. | 1991-09-06 | Traditional | PDF ↗ |
| K913390 | M32 IN-THE-EAR HEARING AID | Philips Hearing Instruments Co. | 1991-08-26 | Traditional | PDF ↗ |
| K913389 | PHILIPS S1594 OTB HEARING AID | Philips Hearing Instruments Co. | 1991-08-26 | Traditional | PDF ↗ |
| K912870 | HEARING AID, UNITRON MODEL UIK | Unitron Industries, Inc. | 1991-07-31 | Traditional | PDF ↗ |
| K912665 | SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID | Resound Corp. | 1991-07-24 | Traditional | PDF ↗ |
| K911183 | NHS 2044P BODY AID, HEARING AID | Magnatone Hearing Aid Corp. | 1991-07-09 | Traditional | PDF ↗ |
| K912571 | PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT | Phonak, Inc. | 1991-06-26 | Traditional | PDF ↗ |
| K911811 | SIEMENS MODEL 604 PP-L, BEHIND-THE-EAR HEARING AID | Siemens Hearing Instruments, Inc. | 1991-06-26 | Traditional | PDF ↗ |
| K912570 | PHONAK PHONICA MODEL 312-C ITE HEARING INSTRUMENT | Phonak, Inc. | 1991-06-26 | Traditional | PDF ↗ |
| K911810 | SIEMENS MODEL 604 PP, BEHIND-THE-EAR HEARING AID | Siemens Hearing Instruments, Inc. | 1991-06-26 | Traditional | PDF ↗ |
| K912204 | TELEX MODEL TLP, IN-THE-EAR | Telex Communications, Inc. | 1991-06-20 | Traditional | PDF ↗ |
| K912154 | QUALITONE MODEL 48 C-WR-BEHIND THE EAR | Qualitone | 1991-06-17 | Traditional | PDF ↗ |
| K912153 | QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR | Qualitone | 1991-06-17 | Traditional | PDF ↗ |
| K912339 | PHILIPS M30 IN-THE-EAR HEARING AID | Philips Hearing Instruments Co. | 1991-06-07 | Traditional | PDF ↗ |
| K912169 | WIDEX MODEL QX IN-THE-EAR HEARING AID | Widex Hearing Aid Co., Inc. | 1991-05-28 | Traditional | PDF ↗ |
| K911706 | MODEL 800, BEHIND-THE-EAR HEARING AID | Electone, Inc. | 1991-05-17 | Traditional | PDF ↗ |
| K911709 | STOCK CANAL, IN-THE-EAR HEARING AID | Electone, Inc. | 1991-05-17 | Traditional | PDF ↗ |
| K911707 | REGAL, BEHIND-THE-EAR HEARING AID | Electone, Inc. | 1991-05-17 | Traditional | PDF ↗ |
| K911708 | MODEL E-50, IN-THE-EAR HEARING AID | Electone, Inc. | 1991-05-17 | Traditional | PDF ↗ |
| K911705 | CHAMPION, BEHIND-THE-EAR HEARING AID | Electone, Inc. | 1991-05-17 | Traditional | PDF ↗ |
Product code ESD · Class I · Ear, Nose, Throat. Data: openFDA.