INPUT COMPRSSION LIMITER WITH ACTIVE TONE CONTROL
FDA 510(k) clearance K952453 · decided 1995-06-21
Clearance details
- K-number
- K952453
- Device name
- INPUT COMPRSSION LIMITER WITH ACTIVE TONE CONTROL
- Applicant
- Argosy Electronics
- Decision
- Substantially Equivalent
- Date received
- 1995-05-25
- Decision date
- 1995-06-21
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- ESD
- Device class
- 1
- Regulation number
- 874.3300
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Lyric4 Hearing Aid (K232999) | Sonova AG | 2024-04-11 |
| LYRIC2 (K130790) | Phonak, LLC | 2013-06-27 |
| LYRIC HEARING AID (K081136) | Insound Medical, Inc. | 2008-05-08 |
| INSOUND XT SERIES HEARING AID (K021867) | Insound Medical, Inc. | 2002-11-19 |
| TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) (K003558) | Siemens Hearing Instruments, Inc. | 2001-04-24 |
| SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL (K984518) | Sonic Innovations, Inc. | 1999-03-12 |
| TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC (K974751) | General Hearing Instruments, Inc. | 1998-03-06 |
| ARGOSY PROGRAMMABLE ONQUE (K974242) | Argosy Electronics | 1998-01-20 |
| SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM (K973880) | Sonix Technologies, Inc. | 1998-01-12 |
| OPUS 2 - CANAL SERIES (ITC) (K974069) | Bernafon-Maico, Inc. | 1997-12-15 |
| OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) (K974152) | Bernafon-Maico, Inc. | 1997-12-15 |
| OPUS 2 - FULL CONCHA SERIES - ITE (K974211) | Bernafon-Maico, Inc. | 1997-12-15 |
Recalls involving this device
No recalls on record reference this clearance.