510(k) K110831 ยท LXB Hearing Aid, Bone Conduction
SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
| Applicant | Sonitus Medical, Inc., San Carlos CA, US |
| Decision | Substantially Equivalent, Jun 21, 2011 |
| Received | Mar 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110831
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2012 | Sonitus Medical Inc. SoundBite Hearing System; Microphone Tube Size 0. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with Terminated |
LXB | None listed |
| Mar 7, 2012 | Sonitus Medical Inc. SoundBite Hearing System; Microphone Tube Size 1. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with Terminated |
LXB | None listed |
| Mar 7, 2012 | Sonitus Medical Inc. SoundBite Hearing System; Microphone Tube Size 2. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with Terminated |
LXB | None listed |
| Mar 7, 2012 | Sonitus Medical Inc. SoundBite Hearing System; Microphone Tube Size 3. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with Terminated |
LXB | None listed |
| Mar 7, 2012 | Sonitus Medical Inc. SoundBite Hearing System; Microphone Tube Size 4. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with Terminated |
LXB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.