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 3 of 14
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K953050 | Z33 | Electone, Inc. | 1995-08-22 | Traditional | PDF ↗ |
| K953052 | AM 260 K-AMP | Electone, Inc. | 1995-08-15 | Traditional | PDF ↗ |
| K953048 | Z22 | Electone, Inc. | 1995-08-15 | Traditional | PDF ↗ |
| K953053 | AM 260 PP | Electone, Inc. | 1995-08-15 | Traditional | PDF ↗ |
| K953054 | AM 260 OHM | Electone, Inc. | 1995-08-15 | Traditional | PDF ↗ |
| K953051 | Z35 | Electone, Inc. | 1995-08-15 | Traditional | PDF ↗ |
| K953049 | Z24 | Electone, Inc. | 1995-08-15 | Traditional | PDF ↗ |
| K952986 | SPI-SECRET PERSONAL INSTRUMENT CIC | Midwest City Hearing Aid Center | 1995-08-07 | Traditional | PDF ↗ |
| K952658 | HEARING AID | Philips Hearing Instruments Co. | 1995-07-28 | Traditional | PDF ↗ |
| K953266 | RESOUND PERSONAL HEARING SYSTEM BT250 MZ W/REMOTE CONTROL OPTION | Resound Corp. | 1995-07-26 | Traditional | PDF ↗ |
| K952940 | PERSONAL PROGRAMMER 2000 | Siemens Hearing Instruments, Inc. | 1995-07-26 | Traditional | PDF ↗ |
| K952820 | MWCHAC 95 C 12345 | Midwest City Hearing Aid Center | 1995-07-21 | Traditional | PDF ↗ |
| K952821 | MWCHAC 95 FS 12345 | Midwest City Hearing Aid Center | 1995-07-21 | Traditional | PDF ↗ |
| K953036 | DB PUSH-PULL HEARING AID | Midwest City Hearing Aid Center | 1995-07-21 | Traditional | PDF ↗ |
| K953038 | DYNAMIC EQ/CLASS D | Midwest City Hearing Aid Center | 1995-07-21 | Traditional | PDF ↗ |
| K953037 | CUSTOM CANAL & FULL CONCHA INSTR (CLASS D CIR OPT) | Midwest City Hearing Aid Center | 1995-07-20 | Traditional | PDF ↗ |
| K951642 | GOLD CD ULTRA MINI CANAL - MODULE | Electone, Inc. | 1995-07-11 | Traditional | PDF ↗ |
| K952452 | OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROL | Argosy Electronics | 1995-07-06 | Traditional | PDF ↗ |
| K952450 | WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL | Argosy Electronics | 1995-07-06 | Traditional | PDF ↗ |
| K952451 | CLASS D LINEAR WITH ACTIVE TONE CONTROL | Argosy Electronics | 1995-07-06 | Traditional | PDF ↗ |
| K952711 | LORI-A | Lori Medical Laboratories, Inc. | 1995-07-03 | Traditional | PDF ↗ |
| K951828 | FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT | Siemens Hearing Instruments, Inc. | 1995-06-30 | Traditional | PDF ↗ |
| K946232 | ACURA-EX | Lustgarten Multi-Tech Intl. | 1995-06-30 | Traditional | PDF ↗ |
| K951587 | BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K | Beltone Electronics Corp. | 1995-06-30 | Traditional | PDF ↗ |
| K950868 | BELTONE COMPOSER 2000 | Beltone Electronics Corp. | 1995-06-28 | Traditional | PDF ↗ |
| K952097 | OTOSONIC (OSI) CF 10-K, 10-D | Beltone Electronics Corp. | 1995-06-28 | Traditional | PDF ↗ |
| K952454 | EXPANDER WITH ACTIVE TONE CONTROL | Argosy Electronics | 1995-06-21 | Traditional | PDF ↗ |
| K952453 | INPUT COMPRSSION LIMITER WITH ACTIVE TONE CONTROL | Argosy Electronics | 1995-06-21 | Traditional | PDF ↗ |
| K952455 | IMPROVED MANHATTAN II | Argosy Electronics | 1995-06-21 | Traditional | PDF ↗ |
| K952229 | WIDEX MODEL LOGO 32 (L32) | Widex Hearing Aid Co., Inc. | 1995-06-19 | Traditional | PDF ↗ |
| K952228 | SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE | Resound Corp. | 1995-06-05 | Traditional | PDF ↗ |
| K952263 | PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT | Siemens Hearing Instruments, Inc. | 1995-06-05 | Traditional | PDF ↗ |
| K951677 | RIONET HEARING AID HM-02 | Authorized Hearing Systems, Inc. | 1995-06-02 | Traditional | PDF ↗ |
| K951896 | INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT | Siemens Hearing Instruments, Inc. | 1995-05-30 | Traditional | PDF ↗ |
| K950963 | AUDIOTECH MODEL SPI | Muskogee Regional Hearing Aid Lab | 1995-05-25 | Traditional | PDF ↗ |
| K943808 | RIONET HM-02 | Rockwin Corp. | 1995-05-24 | Traditional | PDF ↗ |
| K943961 | THE MODEL ACAPPELLA IN THE EAR HEARING AID | Telex Communications, Inc. | 1995-05-15 | Traditional | PDF ↗ |
| K951068 | RESOUND ED4-M MINI-CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-M) | Resound Corp. | 1995-05-12 | Traditional | PDF ↗ |
| K951067 | RESOUND ED4-C CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-C) | Resound Corp. | 1995-05-12 | Traditional | PDF ↗ |
| K951378 | RESOUND PERSONAL HEARING SYSTEM MODELS BTP2 & BTP2/S W/REMOTE CONTROL OPTION | Resound Corp. | 1995-04-27 | Traditional | PDF ↗ |
| K951379 | RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION | Resound Corp. | 1995-04-27 | Traditional | PDF ↗ |
| K951375 | RESOUND PERSONAL HEARING SYSTEM ED3/S-E | Resound Corp. | 1995-04-14 | Traditional | PDF ↗ |
| K951377 | RESOUND PERSONAL HEARING SYSTEM BTP/S-A W/REMOTE CONTROL OPTION | Resound Corp. | 1995-04-14 | Traditional | PDF ↗ |
| K951376 | RESOUND PERSONAL HEARING SYSTEM BT2/S SERIES W/REMOTE CONTROL OPTION | Resound Corp. | 1995-04-14 | Traditional | PDF ↗ |
| K951374 | RESOUND PERSONAL HEARING SYSTEM BT2/S-E | Resound Corp. | 1995-04-14 | Traditional | PDF ↗ |
| K946340 | BELTONE COMPARAFIT | Beltone Electronics Corp. | 1995-04-13 | Traditional | PDF ↗ |
| K950691 | MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID | Miracle-Ear, Inc. | 1995-03-31 | Traditional | PDF ↗ |
| K950759 | UNITRON MODEL ESTEEM | Unitron Industries, Inc. | 1995-03-31 | Traditional | PDF ↗ |
| K950693 | MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AID | Miracle-Ear, Inc. | 1995-03-31 | Traditional | PDF ↗ |
| K950692 | MIRACLE-EAR MODEL PBS PROGRAMMABLE HEARING AID | Miracle-Ear, Inc. | 1995-03-31 | Traditional | PDF ↗ |
| K950458 | SILVER ULTRA MINI CANAL | Electone, Inc. | 1995-03-31 | Traditional | PDF ↗ |
| K950459 | GOLD K AMP ULTRA MINI CANAL | Electone, Inc. | 1995-03-24 | Traditional | PDF ↗ |
| K950460 | GOLD CD ULTRA MINI CANAL | Electone, Inc. | 1995-03-24 | Traditional | PDF ↗ |
| K950758 | DYNA 231X | Phonak, Inc. | 1995-03-21 | Traditional | PDF ↗ |
| K950451 | M-29 PP-PC, M-29 PP-O/PC | Rexton, Inc. | 1995-03-21 | Traditional | PDF ↗ |
| K950637 | MAICO IN-THE-EAR MODEL RD-312 CIC | Maico Hearing Instruments, Inc. | 1995-03-21 | Traditional | PDF ↗ |
| K950912 | MEGA-SIL A-B | Microsonic, Inc. | 1995-03-21 | Traditional | PDF ↗ |
| K945750 | RESOUND(R) RESOURCE(TM) | Resound Corp. | 1995-03-07 | Traditional | PDF ↗ |
| K950381 | OTICON/LOGIC | Oticon, Inc. | 1995-02-27 | Traditional | PDF ↗ |
| K944896 | MATRICS IMPRESSION MATERIAL , SYSTEM | Matrics, Inc. | 1995-02-24 | Traditional | PDF ↗ |
| K944851 | MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC | Rexton, Inc. | 1995-02-22 | Traditional | PDF ↗ |
| K942107 | MAGIC EAR, ELAIN | Novaplex, Inc. | 1995-02-08 | Traditional | PDF ↗ |
| K950080 | VIP | Bell Hearing Instruments, Inc. | 1995-02-08 | Traditional | PDF ↗ |
| K950319 | RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE | Resound Corp. | 1995-02-08 | Traditional | PDF ↗ |
| K946253 | MAICO IN-THE-EAR MODEL RD 201 | Maico Hearing Instruments, Inc. | 1995-01-30 | Traditional | PDF ↗ |
| K946045 | OTICON | Oticon, Inc. | 1995-01-30 | Traditional | PDF ↗ |
| K946323 | UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID | Unitron Industries, Inc. | 1995-01-30 | Traditional | PDF ↗ |
| K946071 | LX-ITC | Widex Hearing Aid Co., Inc. | 1995-01-30 | Traditional | PDF ↗ |
| K945726 | 3M(TM) EAR IMPRESSION MATERIAL | 3M Medical Products Group | 1995-01-27 | Traditional | PDF ↗ |
| K946294 | PHONAK SONO-FORTE 332X-AZ | Phonak, Inc. | 1995-01-26 | Traditional | PDF ↗ |
| K946264 | UNITRON MODEL SOUNG F/S | Unitron Industries, Inc. | 1995-01-26 | Traditional | PDF ↗ |
| K943854 | 3M MODEL 8233 HEARING INSTRUMENT | 3M Company | 1995-01-24 | Traditional | PDF ↗ |
| K945219 | HORMANN HEARING INSTRUMENTS | Hormann, Inc. | 1995-01-20 | Traditional | PDF ↗ |
| K934917 | RESOUND PERSONAL HEARING SYSTEMS MODIFICATION | Resound Corp. | 1995-01-19 | Traditional | PDF ↗ |
| K944980 | SOUND SELECTOR ITE (SSI), BTE (SSB), MINI BTE( SSM) | Hearing Solutions, Inc. | 1995-01-18 | Traditional | PDF ↗ |
| K943380 | SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS | Siemens Hearing Instruments, Inc. | 1995-01-05 | Traditional | PDF ↗ |
| K944986 | EMSEE LABS MODEL C | Emsee Lab of Florida | 1994-12-30 | Traditional | PDF ↗ |
| K944984 | EMSEE LABS MODEL S | Emsee Lab of Florida | 1994-12-30 | Traditional | PDF ↗ |
| K944777 | ORION PPM, PP, PP-D | Rexton, Inc. | 1994-12-30 | Traditional | PDF ↗ |
| K944985 | EMSEE LABS MODE M | Emsee Lab of Florida | 1994-12-30 | Traditional | PDF ↗ |
| K944359 | EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-12 | Rexton, Inc. | 1994-12-29 | Traditional | PDF ↗ |
| K944645 | SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS | Siemens Hearing Instruments, Inc. | 1994-12-27 | Traditional | PDF ↗ |
| K944174 | LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS | Siemens Hearing Instruments, Inc. | 1994-12-27 | Traditional | PDF ↗ |
| K944518 | WIDEX MODEL LOGO 8S | Widex Hearing Aid Co., Inc. | 1994-12-27 | Traditional | PDF ↗ |
| K944404 | MO4 SERIES | Philips Hearing Instruments Co. | 1994-12-27 | Traditional | PDF ↗ |
| K944520 | AIR CONDUCTION HEARING AID | Unitron Industries, Inc. | 1994-12-27 | Traditional | PDF ↗ |
| K945703 | WIDEX MODEL LOGO - L9 | Widex Hearing Aid Co., Inc. | 1994-12-23 | Traditional | PDF ↗ |
| K945710 | IN-THE-EAR HEARING AID | Truetone Hearing Systems, Inc. | 1994-12-23 | Traditional | PDF ↗ |
| K944043 | BTP-A HEARING SYSTEM | Resound Corp. | 1994-12-23 | Traditional | PDF ↗ |
| K944039 | BEHIND THE EAR HEARING AID | Audicraft Hearing Instruments | 1994-12-23 | Traditional | PDF ↗ |
| K944161 | IMAGE | Authorized Hearing Systems, Inc. | 1994-12-21 | Traditional | PDF ↗ |
| K942702 | DEEP CANAL HEARING INSTRUMENT | Rexton, Inc. | 1994-12-21 | Traditional | PDF ↗ |
| K945218 | ACTIVE MODEL CIC | Active Electronics, Inc. | 1994-12-21 | Traditional | PDF ↗ |
| K945780 | FINETONE DISCEET CANAL | Finetone Hearing Instruments | 1994-12-21 | Traditional | PDF ↗ |
| K943016 | ADOBE C.I.C | Widex Hearing Aid Co., Inc. | 1994-12-14 | Traditional | PDF ↗ |
| K945255 | MICROSIL | Microsonic, Inc. | 1994-11-29 | Traditional | PDF ↗ |
| K944009 | HEARING AID (ACCESSORY) | Phoenix Management, Inc. | 1994-11-22 | Traditional | PDF ↗ |
| K944241 | MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AID | Magnatone Hearing Aid Corp. | 1994-11-16 | Traditional | PDF ↗ |
| K942331 | DANAVOX MODEL CIC | Gn Danavox, Inc. | 1994-11-15 | Traditional | PDF ↗ |
| K944097 | COMPASS SOFTWARE MODULE | Widex Hearing Aid Co., Inc. | 1994-11-15 | Traditional | PDF ↗ |
Product code ESD · Class I · Ear, Nose, Throat. Data: openFDA.