SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL— 510(k) K110831
Substantially EquivalentSonitus Medical, Inc.
FDA 510(k) clearance K110831 for SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL, Substantially Equivalent on 2011-06-21. Applicant: Sonitus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Sonitus Medical, Inc.
- Product code
- Code LXB
- Device class
- Class 2
- Regulation
- 21 CFR 874.3302
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Carlos, CA, US
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- K254296 — Ossiclear (Ossiclear System)
- K260452 — 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)
- K261256 — Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
- K250215 — Baha 7 Sound Processor +4 more
More clearances from Sonitus Medical, Inc.
view allAdverse events under product code LXB
product code LXB- Injury
- 2,334
- Total
- 2,334
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.