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 5 of 14
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K934586 | PROGRAMMABLE AIR CONDUCTION BEHIND THE EAR HEARING AID | Unitron Industries, Inc. | 1993-11-19 | Traditional | PDF ↗ |
| K934597 | CLARIFIER II CIRCUIT OPTION | Miracle-Ear, Inc. | 1993-11-19 | Traditional | PDF ↗ |
| K934480 | RIONET HEARING AID HA-73 | Authorized Hearing Systems, Inc. | 1993-11-19 | Traditional | PDF ↗ |
| K934618 | OTOSONIC ADVANCED FULL SHIELD (AFS) | Beltone Electronics Corp. | 1993-11-19 | Traditional | PDF ↗ |
| K931372 | RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM | Resound Corp. | 1993-11-03 | Traditional | PDF ↗ |
| K933546 | V-SIL | Esschem, Inc. | 1993-11-02 | Traditional | PDF ↗ |
| K934452 | HI BAND | Argosy Electronics | 1993-10-13 | Traditional | PDF ↗ |
| K934443 | 2:1 INPUT COMPRESSION | Argosy Electronics | 1993-10-08 | Traditional | PDF ↗ |
| K934448 | POWER 3-CHANNEL-CLOCK | Argosy Electronics | 1993-10-08 | Traditional | PDF ↗ |
| K934446 | POWER MANHATTAN II | Argosy Electronics | 1993-10-08 | Traditional | PDF ↗ |
| K934442 | LINEAR PLUS | Argosy Electronics | 1993-10-08 | Traditional | PDF ↗ |
| K934453 | 3-CHANNEL CLOCK | Argosy Electronics | 1993-10-08 | Traditional | PDF ↗ |
| K934454 | MANHATTAN II | Argosy Electronics | 1993-10-08 | Traditional | PDF ↗ |
| K934444 | K-AMP | Argosy Electronics | 1993-10-08 | Traditional | PDF ↗ |
| K934449 | 3-CHANNEL K-AMP | Argosy Electronics | 1993-10-08 | Traditional | PDF ↗ |
| K934450 | MANHATTAN 3-CHANNEL | Argosy Electronics | 1993-10-08 | Traditional | PDF ↗ |
| K934447 | LINEAR PLUS-POWER | Argosy Electronics | 1993-10-08 | Traditional | PDF ↗ |
| K933989 | RESOLUTION ITC HEARING AID | Starkey Laboratories, Inc. | 1993-10-07 | Traditional | PDF ↗ |
| K933988 | BOSCH EUROSTAR | Starkey Laboratories, Inc. | 1993-10-07 | Traditional | PDF ↗ |
| K933407 | STARKEY TYMPANETTE HEARING AID | Starkey Laboratories, Inc. | 1993-10-07 | Traditional | PDF ↗ |
| K923006 | AS-90 | Qualitone | 1993-09-18 | Traditional | PDF ↗ |
| K933850 | PHILIPS 45 SERIES | Philips Hearing Instruments Co. | 1993-09-07 | Traditional | PDF ↗ |
| K933291 | MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID | Maico Hearing Instruments, Inc. | 1993-08-23 | Traditional | PDF ↗ |
| K933579 | MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID | Telex Communications, Inc. | 1993-08-23 | Traditional | PDF ↗ |
| K933643 | WIDEX MODEL LOGO 6 (L6) | Widex Hearing Aid Co., Inc. | 1993-08-23 | Traditional | PDF ↗ |
| K933640 | WIDEX MODEL LOGO 12 (L12) | Widex Hearing Aid Co., Inc. | 1993-08-23 | Traditional | PDF ↗ |
| K933644 | WIDEX MODEL LOGO 8 (L8) | Widex Hearing Aid Co., Inc. | 1993-08-23 | Traditional | PDF ↗ |
| K933307 | MULTIFOCUS COMPACT BTE HEARING AID | Oticon, Inc. | 1993-08-23 | Traditional | PDF ↗ |
| K932703 | BELTONE PRIMA 2000 | Beltone Electronics Corp. | 1993-08-19 | Traditional | PDF ↗ |
| K930909 | PRIZM HEARING SYSTEM | Audioscience, Inc. | 1993-08-09 | Traditional | PDF ↗ |
| K932670 | OTICON MF | Oticon Corp. | 1993-08-05 | Traditional | PDF ↗ |
| K933036 | GOLD ASP MODULE, ITE | Electone, Inc. | 1993-08-02 | Traditional | PDF ↗ |
| K933042 | SILVER COMPRESSION MODULE, ITE | Electone, Inc. | 1993-08-02 | Traditional | PDF ↗ |
| K933113 | STARKEY TRILOGY II PROGRAMMABLE HEARING AID | Starkey Laboratories, Inc. | 1993-07-27 | Traditional | PDF ↗ |
| K932734 | PHONAK PICO-FORTE SC-2 | Phonak, Inc. | 1993-07-27 | Traditional | PDF ↗ |
| K932735 | PHONAK PICO-FORTE SC-D-2 | Phonak, Inc. | 1993-07-27 | Traditional | PDF ↗ |
| K933095 | 351-AGCO BEHIND-THE-EAR HEARING AID | Telex Communications, Inc. | 1993-07-26 | Traditional | PDF ↗ |
| K931942 | RESOUND PERSONAL HEARING SYSTEM BT-P W/PHS BT-P | Resound Corp. | 1993-07-20 | Traditional | PDF ↗ |
| K926150 | VINYL ADDITION SILICONE SYSTEM | Crown Delta Corp. | 1993-07-14 | Traditional | PDF ↗ |
| K932426 | BELTONE OPERA/OPERA MHP/OPERA MAX | Beltone Electronics Corp. | 1993-07-14 | Traditional | PDF ↗ |
| K932175 | PHONAK LEXA 231X ITE SERIES HEARING SINSTRUMENT | Phonak, Inc. | 1993-07-08 | Traditional | PDF ↗ |
| K932058 | BELTONE OPTIMA 2000 ITE HEARING AID | Beltone Electronics Corp. | 1993-07-02 | Traditional | PDF ↗ |
| K931881 | IN THE CANAL AID OTOSONIC ACS II WITH SRR | Beltone Electronics Corp. | 1993-07-02 | Traditional | PDF ↗ |
| K922502 | M32 IN THE EAR HEARING AID | Electone, Inc. | 1993-06-24 | Traditional | PDF ↗ |
| K922501 | M30 IN THE EAR HEARING AID | Electone, Inc. | 1993-06-24 | Traditional | PDF ↗ |
| K931975 | AUDIOTECH MODEL DP | Muskogee Regional Hearing Aid Lab | 1993-06-22 | Traditional | PDF ↗ |
| K932105 | HEARING AIDS | Katz Hearing Aid Center | 1993-06-14 | Traditional | PDF ↗ |
| K932189 | IN-THE-EAR HEARING AID | Lifestyle Hearing, Inc. | 1993-06-14 | Traditional | PDF ↗ |
| K931984 | PERFECT EAR/PE | Perfect Ear | 1993-06-08 | Traditional | PDF ↗ |
| K931040 | MT 80 SP | Maico Hearing Instruments, Inc. | 1993-06-01 | Traditional | PDF ↗ |
| K931161 | SERIES STAR 22 - BEHIND THE EAR HEARING AID | Maico Hearing Instruments, Inc. | 1993-06-01 | Traditional | PDF ↗ |
| K931160 | SERIES STAR 66 BEKHIND THE EAR HEARING AID | Maico Hearing Instruments, Inc. | 1993-06-01 | Traditional | PDF ↗ |
| K931041 | STAR 42 PP-SP, STAR 42 PP-SL (T100) | Maico Hearing Instruments, Inc. | 1993-06-01 | Traditional | PDF ↗ |
| K931035 | MODELS 33PP, 33PP ANR, & 33PP SUPER HEARING AID | Maico Hearing Instruments, Inc. | 1993-06-01 | Traditional | PDF ↗ |
| K931590 | ITE MODEL ADOBE 100 FULL CUSTOM | Widex Hearing Aid Co., Inc. | 1993-05-19 | Traditional | PDF ↗ |
| K931591 | ITC MODEL ADOBE 100 CANAL | Widex Hearing Aid Co., Inc. | 1993-05-19 | Traditional | PDF ↗ |
| K931023 | IN-THE-EAR HEARING AID | Hearing Improvement | 1993-05-05 | Traditional | PDF ↗ |
| K931320 | RIONET HEARING AID HB-53W | Rion Co. Ltd. Dba Rion Acoustic Device | 1993-05-05 | Traditional | PDF ↗ |
| K931157 | BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP | Telex Communications, Inc. | 1993-04-14 | Traditional | PDF ↗ |
| K931134 | BEHIND-THE-EAR HEARING AID, TELEX MODEL 361-PP | Telex Communications, Inc. | 1993-04-14 | Traditional | PDF ↗ |
| K931158 | MEMOREX MODEL 361-AGCO HEARING AID | Telex Communications, Inc. | 1993-04-14 | Traditional | PDF ↗ |
| K930998 | SIEMENS MODEL 584-P-GC | Siemens Hearing Instruments, Inc. | 1993-04-12 | Traditional | PDF ↗ |
| K930999 | SIEMENS MODEL 584-P-AI | Siemens Hearing Instruments, Inc. | 1993-04-12 | Traditional | PDF ↗ |
| K931000 | SIEMENS MODEL 584-P-AI-D | Siemens Hearing Instruments, Inc. | 1993-04-12 | Traditional | PDF ↗ |
| K930721 | RIONET HEARING AID HB-53S | Authorized Hearing Systems, Inc. | 1993-04-07 | Traditional | PDF ↗ |
| K930542 | HEARING AID (ALL-IN-THE-EAR) | Action Labs, Inc. | 1993-04-07 | Traditional | PDF ↗ |
| K930271 | BEHIND-THE-EAR HEARING AID | Audina Hearing Instrument | 1993-03-18 | Traditional | PDF ↗ |
| K930805 | CE-9 IN-THE-EAR HEARING AID | Starkey Laboratories, Inc. | 1993-03-18 | Traditional | PDF ↗ |
| K930853 | INTRA V AND SECRET EAR III | Starkey Laboratories, Inc. | 1993-03-18 | Traditional | PDF ↗ |
| K930715 | WIDEX MODEL DX HEARING AID | Widex Hearing Aid Co., Inc. | 1993-03-18 | Traditional | PDF ↗ |
| K930598 | OTOSONIC FSD, IN-THE-EAR HEARING AID | Beltone Electronics Corp. | 1993-03-18 | Traditional | PDF ↗ |
| K930541 | VOICEMODE, ITE, AIR-CONDUCTION HEARING AID | Personal Sound Technologies, Inc. | 1993-03-03 | Traditional | PDF ↗ |
| K930310 | BELTONE OPTIMA 2000 CLEARVOICE SERIES, IN-THE-EAR | Beltone Electronics Corp. | 1993-03-01 | Traditional | PDF ↗ |
| K930318 | BELTONE OPERA LOR, ITC | Beltone Electronics Corp. | 1993-03-01 | Traditional | PDF ↗ |
| K926092 | MIRACLE-EAR MODEL HL | Miracle-Ear, Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K926091 | AUDIOTONE MODEL A-98 | Miracle-Ear, Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K925600 | VISTA 4000 SIGMA | Unitron Industries, Inc. | 1993-02-08 | Traditional | PDF ↗ |
| K926476 | SOUNDCHOICE WITH VARIABLE SLOPE | Bausch & Lomb, Inc. | 1993-02-02 | Traditional | PDF ↗ |
| K926085 | WIDEX MODEL D16 | Widex Hearing Aid Co., Inc. | 1993-02-02 | Traditional | PDF ↗ |
| K930145 | PHONAK PICONET 231-X | Phonak, Inc. | 1993-02-01 | Traditional | PDF ↗ |
| K926244 | WIDEX MODEL D8 (HEARING AID) | Widex Hearing Aid Co., Inc. | 1993-01-27 | Traditional | PDF ↗ |
| K924888 | P54 HEARING AID | Electone, Inc. | 1992-11-24 | Traditional | PDF ↗ |
| K924887 | P54-0 BEHIND THE EAR HEARING AID | Electone, Inc. | 1992-11-24 | Traditional | PDF ↗ |
| K924350 | HEARING AID (ALL-IN-THE-EAR) | Ear Masters, Inc. | 1992-11-16 | Traditional | PDF ↗ |
| K925103 | AAHS HEARING AID | American Hearing Systems, Inc. | 1992-11-06 | Traditional | PDF ↗ |
| K924914 | PHONAK PICO-FORTE PPC-P-2 BTE HEARING INSTRUMENT | Phonak, Inc. | 1992-11-04 | Traditional | PDF ↗ |
| K924913 | PHONAK PICO-FORTE PPC-L-P-2 BTE HEARING INSTR | Phonak, Inc. | 1992-11-04 | Traditional | PDF ↗ |
| K924911 | PHONAK PICO-FORTE PP-SC-2 BTE HEARING INSTRUMENT | Phonak, Inc. | 1992-11-04 | Traditional | PDF ↗ |
| K924185 | DFS GENIUS BTE | Gn Danavox, Inc. | 1992-11-03 | Traditional | PDF ↗ |
| K924912 | PHONAK PICO-FORTE C-2 BTE HEARING INSTRUMENT | Phonak, Inc. | 1992-11-03 | Traditional | PDF ↗ |
| K923292 | ITC HEARING AID CLUB MODEL LM50 | Club Hearing Instruments A/S | 1992-10-05 | Traditional | PDF ↗ |
| K924450 | MEDIPHONIX CUSTOM FULL SHELL CUSTOM CANAL | Mediphonix, Inc. | 1992-10-05 | Traditional | PDF ↗ |
| K923735 | SOUNDCHOICE K-AMP | Bausch & Lomb, Inc. | 1992-09-28 | Traditional | PDF ↗ |
| K923071 | DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT | Life-Tech Intl., Inc. | 1992-09-28 | Traditional | PDF ↗ |
| K923801 | RIONET HB75-AL BTE AID | Authorized Hearing Systems, Inc. | 1992-09-28 | Traditional | PDF ↗ |
| K923743 | BTE WITH ACCESSORY ATTACHED | Phonak, Inc. | 1992-09-28 | Traditional | PDF ↗ |
| K923296 | BTE HEARING AID CLUB MODEL ST70 | Club Hearing Instruments A/S | 1992-09-23 | Traditional | PDF ↗ |
| K923295 | ITC HEARING AID CLUB MODEL LM40 | Club Hearing Instruments A/S | 1992-09-23 | Traditional | PDF ↗ |
| K923293 | ITC HEARING AID CLUB MODEL LM50H | Club Hearing Instruments A/S | 1992-09-23 | Traditional | PDF ↗ |
| K923294 | BTE HEARING AID CLUB MODEL: ST60 | Club Hearing Instruments A/S | 1992-09-23 | Traditional | PDF ↗ |
Product code ESD · Class I · Ear, Nose, Throat. Data: openFDA.