510(k) K940667
- Device
- STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID
- Applicant
- STARKEY LABORATORIES, INC.
- 510(k) number
- K940667
- Product code
- ESD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-08-09
- Date received
- 1994-02-16
- Regulation
- 874.3300
- Classification name
- Hearing Aid, Air Conduction
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICK STROMBERG
- Address
- 6700 Washington Ave. S. Eden Prairie MN US 55344 55344
FDA Registration Numbers#
- 3008264111
- 3010602043
- 3027487235
- 3037001880
- 1052698
- 2240713
- 1044692
- 3004929038
- 3009523076
- 9612197
- 3015763534
- 3017903826
- 3017610929
- 3009307953
- 9680954
- 3017618900
- 3017207990
- 3005465494
- 3003610251
- 3002159143
- 1929340
- 3005785669
- 2523819
- 3014888923
- 3030535004
- 3017293064
- 2430101
- 3016587556
- 1056339
- 2182204
- 3005650109
- 3006792041
- 3026048380
- 3014844046
- 3019414808
- 3020998569
- 3003303986
- 3006312495
- 2523532
- 3030396448
- 3009617411
- 3006544364
- 2125608
- 3036679760
- 3019622583
- 3004582233
- 3022507139
- 1526534
- 3011350813
- 3011586575
- 3016630774
- 3006979687
- 3034880867
- 8021514
- 3015990335
- 3023007429
- 3018999226
- 3017910381
- 3005581270
- 3017441596
- 3007277229
- 3030220356
- 2184059
- 3005053820
- 3013596029
- 3012494290
- 3035374295
- 3006076696
- 3001620590
- 3043178566
- 3004003391
- 3010408889
- 3027643666
- 3027344214
- 3008713760
- 3018094156
- 3021334102
- 2183732
- 3015140207
Source Documents#
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 |
| K974211 | OPUS 2 - FULL CONCHA SERIES - ITE | Bernafon-Maico, Inc. | 1997-12-15 |
| K974152 | OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) | Bernafon-Maico, Inc. | 1997-12-15 |
| K974069 | OPUS 2 - CANAL SERIES (ITC) | Bernafon-Maico, Inc. | 1997-12-15 |
| K974340 | UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE | Unitron Industries, Inc. | 1997-12-12 |
| K974339 | UNITRON MODEL SOUND F/XD PROGRAMMABLE | Unitron Industries, Inc. | 1997-12-12 |
| K974338 | UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) | Unitron Industries, Inc. | 1997-12-12 |
Legacy Summary#
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FDA Review#
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