FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229
K Number: K935701
·
Decision May 10, 1994
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
50
Applicant Total
60
Review Days
161
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Basic Information
- Device Name
- VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229
- K Number
- K935701
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3302
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Starkey Laboratories, Inc.
- Date Received
- November 30, 1993
- Decision Date
- May 10, 1994
- Product Code
- LXB
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LXB | Hearing Aid, Bone Conduction | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LXB), ordered by most recent decision date.
Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)
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FDA Class 2
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Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand
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FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Starkey Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K201370 | Multiflex Tinnitus Technology | Jun 19, 2020 | Substantially Equivalent |
| K030180 | CRESCENT TINNITUS RETAINING SOUND GENERATOR | Sep 17, 2003 | Substantially Equivalent |
| K970952 | PRECISE IMPRESSION KIT | May 2, 1997 | Substantially Equivalent |
| K964245 | PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS | Feb 4, 1997 | Substantially Equivalent |
| K964340 | PORTAREM-3000, PFS-6000 | Jan 10, 1997 | Substantially Equivalent |
| K964216 | STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER | Dec 6, 1996 | Substantially Equivalent |
| K964214 | STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS | Nov 27, 1996 | Substantially Equivalent |
| K964244 | STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS | Nov 27, 1996 | Substantially Equivalent |
| K963838 | STARKEY TM AIR CONDUCTION TINNITUS MASKER | Nov 26, 1996 | Substantially Equivalent |
| K963995 | STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER | Nov 26, 1996 | Substantially Equivalent |