510(k) K761216
- Device
- HEARING AIDS (MODEL E-552 S-712)
- Applicant
- VICON INSTRUMENT CO.
- 510(k) number
- K761216
- Product code
- ESD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-12-16
- Date received
- 1976-12-07
- Regulation
- 874.3300
- Classification name
- Hearing Aid, Air Conduction
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code ESD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232999 | Lyric4 Hearing Aid | Sonova AG | 2024-04-11 |
| K130790 | LYRIC2 | Phonak, LLC | 2013-06-27 |
| K081136 | LYRIC HEARING AID | Insound Medical, Inc. | 2008-05-08 |
| K021867 | INSOUND XT SERIES HEARING AID | Insound Medical, Inc. | 2002-11-19 |
| K003558 | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | Siemens Hearing Instruments, Inc. | 2001-04-24 |
| K984518 | SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL | Sonic Innovations, Inc. | 1999-03-12 |
| K974751 | TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC | General Hearing Instruments, Inc. | 1998-03-06 |
| K974242 | ARGOSY PROGRAMMABLE ONQUE | Argosy Electronics | 1998-01-20 |
| K973880 | SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM | Sonix Technologies, Inc. | 1998-01-12 |
| K974069 | OPUS 2 - CANAL SERIES (ITC) | Bernafon-Maico, Inc. | 1997-12-15 |
| K974152 | OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) | Bernafon-Maico, Inc. | 1997-12-15 |
| K974211 | OPUS 2 - FULL CONCHA SERIES - ITE | Bernafon-Maico, Inc. | 1997-12-15 |
| K974081 | RESOUND STEALTH CIC | Resound Corp. | 1997-12-12 |
| K974129 | HI-69E, HI-69N, HI-69P | Rockwin Corp. | 1997-12-12 |
| K974257 | RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) | Resound Corp. | 1997-12-12 |
Legacy Summary#
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FDA Review#
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