SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
FDA 510(k) clearance K110831 · decided 2011-06-21
Clearance details
- K-number
- K110831
- Device name
- SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
- Applicant
- Sonitus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-25
- Decision date
- 2011-06-21
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- LXB
- Device class
- 2
- Regulation number
- 874.3302
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- San Carlos, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sonitus Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SoundBite Hearing System; Microphone Tube Size 0. For use in patients with moderately seve recall (Z-1179-2012) | Sonitus Medical Inc. | 2012-03-07 |
| SoundBite Hearing System; Microphone Tube Size 1. For use in patients with moderately seve recall (Z-1180-2012) | Sonitus Medical Inc. | 2012-03-07 |
| SoundBite Hearing System; Microphone Tube Size 2. For use in patients with moderately seve recall (Z-1181-2012) | Sonitus Medical Inc. | 2012-03-07 |
| SoundBite Hearing System; Microphone Tube Size 3. For use in patients with moderately seve recall (Z-1182-2012) | Sonitus Medical Inc. | 2012-03-07 |
| SoundBite Hearing System; Microphone Tube Size 4. For use in patients with moderately seve recall (Z-1183-2012) | Sonitus Medical Inc. | 2012-03-07 |