Company ยท US
Sophono, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2016. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LXB | Hearing Aid, Bone Conduction | 5 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 16, 2016 | K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration Sophono, Inc. | LXB |
| Nov 22, 2013 | K132189 | OTOMAG BONE CONDUCATION HEARING SYSTEM Sophono, Inc. | LXB |
| Apr 8, 2013 | K123962 | OTOMAG BONE CONDUCTION HEARING SYSTEM Sophono, Inc. | LXB |
| May 23, 2011 | K102199 | OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) Sophono, Inc. | LXB |
| May 18, 2010 | K100193 | OTOMAG BONE CONDUCTION HEARING SYSTEM Sophono, Inc. | LXB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||